Trial Outcomes & Findings for Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (NCT NCT03631199)

Last Updated: 2026-02-06

Results Overview

A DLT was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

673 participants

Primary outcome timeframe

During the first 42 days of dosing

Results posted on

2026-02-06

Participant Flow

All inclusion and exclusion criteria were checked at screening.

Participant milestones

Participant milestones
Measure	Part 1: Cohort A Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.	Part 1: Cohort B Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Overall Study STARTED	10	11	9	320	323
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	10	11	9	320	323

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Cohort A Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.	Part 1: Cohort B Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Overall Study Progressive disease	9	5	5	149	148
Overall Study Physician Decision	0	2	3	19	13
Overall Study Adverse Event	1	1	0	28	29
Overall Study Death	0	1	0	35	48
Overall Study Subject decision	0	1	0	12	12
Overall Study No treated	0	0	0	0	1
Overall Study Treatment ongoing	0	1	1	76	71
Overall Study Guardian decision	0	0	0	1	1

Baseline Characteristics

Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 2: Placebo+Pembro+CTx n=323 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Total n=673 Participants Total of all reporting groups	Part 1: Cohort A n=10 Participants Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.	Part 1: Cohort B n=11 Participants Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.	Part 1: Cohort C n=9 Participants Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx n=320 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
Age, Continuous	62.7 years STANDARD_DEVIATION 8.74 • n=172 Participants	62.2 years STANDARD_DEVIATION 9.23 • n=896 Participants	64.5 years STANDARD_DEVIATION 6.57 • n=192 Participants	57.9 years STANDARD_DEVIATION 13.03 • n=170 Participants	63.1 years STANDARD_DEVIATION 7.18 • n=185 Participants	61.7 years STANDARD_DEVIATION 9.65 • n=177 Participants
Sex: Female, Male Female	91 Participants n=172 Participants	192 Participants n=896 Participants	0 Participants n=192 Participants	5 Participants n=170 Participants	3 Participants n=185 Participants	93 Participants n=177 Participants
Sex: Female, Male Male	232 Participants n=172 Participants	481 Participants n=896 Participants	10 Participants n=192 Participants	6 Participants n=170 Participants	6 Participants n=185 Participants	227 Participants n=177 Participants
Race/Ethnicity, Customized White	180 Participants n=172 Participants	380 Participants n=896 Participants	5 Participants n=192 Participants	3 Participants n=170 Participants	7 Participants n=185 Participants	185 Participants n=177 Participants
Race/Ethnicity, Customized Asian	117 Participants n=172 Participants	244 Participants n=896 Participants	5 Participants n=192 Participants	5 Participants n=170 Participants	2 Participants n=185 Participants	115 Participants n=177 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=172 Participants	5 Participants n=896 Participants	0 Participants n=192 Participants	0 Participants n=170 Participants	0 Participants n=185 Participants	1 Participants n=177 Participants
Race/Ethnicity, Customized Multiple	2 Participants n=172 Participants	2 Participants n=896 Participants	0 Participants n=192 Participants	0 Participants n=170 Participants	0 Participants n=185 Participants	0 Participants n=177 Participants
Race/Ethnicity, Customized Missing	20 Participants n=172 Participants	42 Participants n=896 Participants	0 Participants n=192 Participants	3 Participants n=170 Participants	0 Participants n=185 Participants	19 Participants n=177 Participants

PRIMARY outcome

Timeframe: During the first 42 days of dosing

Population: The dose-determining set (DDS) included all participants from the safety set who met the minimum exposure criterion and had sufficient safety evaluations, or experienced a dose-limiting toxicity (DLT) during the first 42 days (6 weeks) of dosing. Data are reported for Part 1 only.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=10 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=10 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C n=9 Participants Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs)	0 Participants	0 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: 18 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.

Progression free survival was defined as the time from randomization to the date of the first documented radiological progression using RECIST 1.1 (Response evaluation criteria in solid tumor) or death due to any cause.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=320 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=323 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Progression-free Survival (PFS) Per Investigator Assessment Using RECIST v1.1	6.77 months Interval 5.62 to 7.75	6.77 months Interval 5.52 to 6.93	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 32 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.

Overall survival is defined as the time from date of randomization to date of death due to any cause.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=320 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=323 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Survival (OS) Per Investigator Assessment Using RECIST v1.1	20.83 months Interval 16.26 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	20.17 months Interval 16.23 to 22.37	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 14 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 1 only.

ORR was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=10 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=11 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C n=9 Participants Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 1 (Safety Run-in): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1	20.0 percentage of participants Interval 2.5 to 55.6	72.7 percentage of participants Interval 39.0 to 94.0	44.4 percentage of participants Interval 13.7 to 78.8	—	—

SECONDARY outcome

Timeframe: Up to approximately 26 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=320 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=323 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1	45.6 percentage of participants Interval 40.1 to 51.3	45.5 percentage of participants Interval 40.0 to 51.1	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 14 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 1 only.

Disease control rate was defined as the percentage of participants with complete response (CR) or partial response (PR) or participants with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=10 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=11 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C n=9 Participants Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 1 (Safety run-in): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1	70.0 percentage of participants Interval 34.8 to 93.3	81.8 percentage of participants Interval 48.2 to 97.7	77.8 percentage of participants Interval 40.0 to 97.2	—	—

SECONDARY outcome

Timeframe: Up to approximately 26 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=320 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=323 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1	86.9 percentage of participants Interval 82.7 to 90.4	84.8 percentage of participants Interval 80.4 to 88.6	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 25 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Participants who never achieved a best overall response of CR or PR were excluded from the analysis. Data are reported for responders in Part 1 only.

Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. DOR only applied to participants whose best overall response was CR or PR based on tumor response data per local review. If a participant did not have an event, DOR was censored at the date of last adequate tumor assessment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=2 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=8 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C n=4 Participants Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 1 (Safety run-in): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1	7.43 months Interval 4.93 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	18.50 months Interval 6.34 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	8.15 months Interval 5.55 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	—	—

SECONDARY outcome

Timeframe: Up to approximately 26 months

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=146 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=147 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1	14.26 months Interval 10.41 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	13.60 months Interval 10.32 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 26 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for responders in Part 2 only.

Time to response (TTR) was defined as duration of time between the date of randomization and the date of first documented response of either CR or PR, according to RECIST 1.1 criteria. Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=146 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=147 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Response (TTR) Per Investigator Assessment Using RECIST v1.1	NA months Interval 8.94 to The median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.	NA months Interval 4.99 to The median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.	—	—	—

SECONDARY outcome

Timeframe: Predose (0 hours (h)) on Day 1 of Cycles 1, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26, 78 and 130 days after last dose

Participants with at least one ADA-positive sample.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 26 months

Population: The safety set comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. The data analysis applied to the Part 2 Canakinumab+pembro+CTx arm only.

Participants with at least one ADA-positive sample.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=320 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Number of Participants With Antidrug Antibodies (ADA) of Canakinumab Baseline	3 Participants	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Number of Participants With Antidrug Antibodies (ADA) of Canakinumab On treatment	2 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Predose (0 h) on Day 1 of Cycles 1, 2, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26 days after last dose

Participants with at least one ADA-positive sample.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 26 months

Population: The safety set comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.

Participants with at least one ADA-positive sample.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=320 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=322 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Antidrug Antibodies (ADA) of Pembrolizumab Baseline	2 Participants	1 Participants	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Antidrug Antibodies (ADA) of Pembrolizumab On treatment	7 Participants	2 Participants	—	—	—

SECONDARY outcome

Timeframe: Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, Post dose on Cycle 5 day 8, at end of treatment & then at 26, 78 and 130 days after last dose (Cycle length =21 days)

Population: The pharmacokinetic (PK) analysis set - canakinumab included all participants who received at least one dose of canakinumab and had at least one evaluable PK sample for canakinumab. Data are reported for Part 1 only.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=9 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=11 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C n=9 Participants Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 1 (Safety Run-in): Serum Canakinumab Concentration Cycle 1, Day 1, 0 hour n=9,11,9	0 μg/mL Geometric Coefficient of Variation 0	0 μg/mL Geometric Coefficient of Variation 0	0 μg/mL Geometric Coefficient of Variation 0	—	—
Part 1 (Safety Run-in): Serum Canakinumab Concentration Cycle 1, Day 1, 24 hour n=8,11,9	4.43 μg/mL Geometric Coefficient of Variation 72.1	4.97 μg/mL Geometric Coefficient of Variation 113.5	4.57 μg/mL Geometric Coefficient of Variation 67.1	—	—
Part 1 (Safety Run-in): Serum Canakinumab Concentration Cycle 1, Day 1, 168 hour n=9,11,9	12.1 μg/mL Geometric Coefficient of Variation 44.5	14.0 μg/mL Geometric Coefficient of Variation 61.7	12.8 μg/mL Geometric Coefficient of Variation 33.2	—	—
Part 1 (Safety Run-in): Serum Canakinumab Concentration Cycle 1, Day 1, 336 hour n=8,10,8	11.1 μg/mL Geometric Coefficient of Variation 35.0	12.3 μg/mL Geometric Coefficient of Variation 55.2	10.9 μg/mL Geometric Coefficient of Variation 35.9	—	—
Part 1 (Safety Run-in): Serum Canakinumab Concentration Cycle 2, Day 1, 0 hour n=9,9,7	10.2 μg/mL Geometric Coefficient of Variation 33.6	8.80 μg/mL Geometric Coefficient of Variation 49.4	8.69 μg/mL Geometric Coefficient of Variation 34.5	—	—
Part 1 (Safety Run-in): Serum Canakinumab Concentration Cycle 3, Day 1, 0 hour n=7,9,8	16.9 μg/mL Geometric Coefficient of Variation 31.3	20.3 μg/mL Geometric Coefficient of Variation 40.3	17.1 μg/mL Geometric Coefficient of Variation 16.4	—	—
Part 1 (Safety Run-in): Serum Canakinumab Concentration Cycle 5, Day 1, 0 hour n=4,7,6	26.9 μg/mL Geometric Coefficient of Variation 41.8	35.6 μg/mL Geometric Coefficient of Variation 47.6	22.4 μg/mL Geometric Coefficient of Variation 39.0	—	—
Part 1 (Safety Run-in): Serum Canakinumab Concentration Cycle 5, Day 1, 168 hour n=5,9,4	32.1 μg/mL Geometric Coefficient of Variation 33.1	49.8 μg/mL Geometric Coefficient of Variation 42.5	32.7 μg/mL Geometric Coefficient of Variation 22.7	—	—
Part 1 (Safety Run-in): Serum Canakinumab Concentration Cycle 6, Day 1, 0 hour n=3,7,6	32.2 μg/mL Geometric Coefficient of Variation 40.0	36.8 μg/mL Geometric Coefficient of Variation 47.8	26.3 μg/mL Geometric Coefficient of Variation 27.4	—	—
Part 1 (Safety Run-in): Serum Canakinumab Concentration Cycle 8, Day 1, 0 hour n=3,7,4	37.7 μg/mL Geometric Coefficient of Variation 27.5	45.8 μg/mL Geometric Coefficient of Variation 38.6	29.9 μg/mL Geometric Coefficient of Variation 29.6	—	—
Part 1 (Safety Run-in): Serum Canakinumab Concentration Cycle 12, Day 1, 0 hour n=2,6,4	40.6 μg/mL Geometric Coefficient of Variation 90.4	52.2 μg/mL Geometric Coefficient of Variation 42.9	32.4 μg/mL Geometric Coefficient of Variation 41.0	—	—
Part 1 (Safety Run-in): Serum Canakinumab Concentration Cycle 16, Day 1, 0 hour n=1,5,4	68.2 μg/mL Geometric Coefficient of Variation 0	41.8 μg/mL Geometric Coefficient of Variation 67.3	31.0 μg/mL Geometric Coefficient of Variation 35.0	—	—
Part 1 (Safety Run-in): Serum Canakinumab Concentration Cycle 4, Day 1, 0 hour n=8,8,6	23.1 μg/mL Geometric Coefficient of Variation 29.0	26.6 μg/mL Geometric Coefficient of Variation 35.0	19.4 μg/mL Geometric Coefficient of Variation 29.2	—	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=302 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration Cycle 1, Day 1, 0 hour n=291	0 μg/mL Geometric Coefficient of Variation 0	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration Cycle 1, Day 1, 24 hour n=263	5.36 μg/mL Geometric Coefficient of Variation 99.3	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration Cycle 1, Day 1, 168 hour n=271	12.3 μg/mL Geometric Coefficient of Variation 52.1	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration Cycle 1, Day 1, 336 hour n=272	10.8 μg/mL Geometric Coefficient of Variation 47.2	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration Cycle 2, Day 1, 0 hour n=228	8.82 μg/mL Geometric Coefficient of Variation 46.8	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration Cycle 3, Day 1, 0 hour n=181	15.2 μg/mL Geometric Coefficient of Variation 40.1	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration Cycle 4, Day 1, 0 hour n=166	18.6 μg/mL Geometric Coefficient of Variation 44.4	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration Cycle 5, Day 1, 0 hour n=154	22.5 μg/mL Geometric Coefficient of Variation 42.9	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration Cycle 5, Day 1, 168 hour n=174	33.8 μg/mL Geometric Coefficient of Variation 42.2	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration Cycle 6, Day 1, 0 hour n=181	25.0 μg/mL Geometric Coefficient of Variation 47.5	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration Cycle 8, Day 1, 0 hour n=144	29.0 μg/mL Geometric Coefficient of Variation 46.9	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration Cycle 12, Day 1, 0 hour n=124	32.3 μg/mL Geometric Coefficient of Variation 49.8	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration Cycle 16, Day 1, 0 hour n=91	33.0 μg/mL Geometric Coefficient of Variation 49.0	—	—	—	—

SECONDARY outcome

Timeframe: Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)

Population: The pharmacokinetic (PK) analysis set -pembrolizumab included all participants who received at least one dose of pembrolizumab and had at least one evaluable PK sample for pembrolizumab. Data are reported for Part 1 only.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=9 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=11 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C n=9 Participants Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration Cycle 1, Day 1, 0 hour n=9,11,9	0 μg/mL Geometric Coefficient of Variation 0	0 μg/mL Geometric Coefficient of Variation 0	0 μg/mL Geometric Coefficient of Variation 0	—	—
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration Cycle 1, Day 1, end-of-infusion, n=9,11,7	53.9 μg/mL Geometric Coefficient of Variation 29.8	52.9 μg/mL Geometric Coefficient of Variation 41.9	48.1 μg/mL Geometric Coefficient of Variation 17.7	—	—
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration Cycle 1, Day 1, 24 hour n=7,11,9	40.5 μg/mL Geometric Coefficient of Variation 26.7	43.0 μg/mL Geometric Coefficient of Variation 35.1	41.4 μg/mL Geometric Coefficient of Variation 23.4	—	—
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration Cycle 1, Day 1, 168 hour n=9,11,9	19.0 μg/mL Geometric Coefficient of Variation 49.4	21.7 μg/mL Geometric Coefficient of Variation 42.9	18.7 μg/mL Geometric Coefficient of Variation 17.3	—	—
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration Cycle 1, Day 1, 336 hour n=9,11,8	15.1 μg/mL Geometric Coefficient of Variation 28.8	14.7 μg/mL Geometric Coefficient of Variation 40.6	12.5 μg/mL Geometric Coefficient of Variation 25.5	—	—
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration Cycle 2, Day 1, 0 hour n=9,9,7	12.2 μg/mL Geometric Coefficient of Variation 36.3	14.5 μg/mL Geometric Coefficient of Variation 49.2	10.5 μg/mL Geometric Coefficient of Variation 13.0	—	—
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration Cycle 3, Day 1, 0 hour n=7,9,7	21.0 μg/mL Geometric Coefficient of Variation 38.2	22.5 μg/mL Geometric Coefficient of Variation 46.8	15.5 μg/mL Geometric Coefficient of Variation 27.2	—	—
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration Cycle 4, Day 1, 0 hour n=8,8,6	27.8 μg/mL Geometric Coefficient of Variation 31.4	33.0 μg/mL Geometric Coefficient of Variation 108.5	23.5 μg/mL Geometric Coefficient of Variation 37.2	—	—
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration Cycle 5, Day 1, 0 hour n=5,7,6	28.6 μg/mL Geometric Coefficient of Variation 31.9	35.5 μg/mL Geometric Coefficient of Variation 44.3	28.5 μg/mL Geometric Coefficient of Variation 82.0	—	—
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration Cycle 5, Day 1, end-of-infusion n=5,7,5	77.7 μg/mL Geometric Coefficient of Variation 19.7	99.3 μg/mL Geometric Coefficient of Variation 29.6	57.4 μg/mL Geometric Coefficient of Variation 51.5	—	—
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration Cycle 6, Day 1, 0 hour n=2,7,5	30.6 μg/mL Geometric Coefficient of Variation 68.8	37.0 μg/mL Geometric Coefficient of Variation 33.6	26.6 μg/mL Geometric Coefficient of Variation 31.2	—	—
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration Cycle 8, Day 1, 0 hour n=3,7,3	46.4 μg/mL Geometric Coefficient of Variation 16.2	45.3 μg/mL Geometric Coefficient of Variation 43.8	35.0 μg/mL Geometric Coefficient of Variation 52.0	—	—
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration Cycle 16, Day 1, 0 hour n=1,5,1	39.8 μg/mL Geometric Coefficient of Variation 0	43.4 μg/mL Geometric Coefficient of Variation 84.5	27.2 μg/mL Geometric Coefficient of Variation 0	—	—
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration Cycle 12, Day 1, 0 hour n=1,7,1	76.1 μg/mL Geometric Coefficient of Variation 0	42.9 μg/mL Geometric Coefficient of Variation 68.8	20.5 μg/mL Geometric Coefficient of Variation 0	—	—

SECONDARY outcome

Timeframe: Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=36 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=36 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration Cycle 5, Day 1, 0 hours n=15,22	28.6 μg/mL Geometric Coefficient of Variation 38.6	26.5 μg/mL Geometric Coefficient of Variation 55.0	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration Cycle 5, Day 1, end-of-infusion n=18,21	66.3 μg/mL Geometric Coefficient of Variation 42.6	70.9 μg/mL Geometric Coefficient of Variation 41.5	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration Cycle 6, Day 1, 0 hours n=14,17	34.0 μg/mL Geometric Coefficient of Variation 69.0	32.2 μg/mL Geometric Coefficient of Variation 71.5	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration Cycle 8, Day 1, 0 hours n=16,17	36.0 μg/mL Geometric Coefficient of Variation 53.2	30.1 μg/mL Geometric Coefficient of Variation 57.4	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration Cycle 12, Day 1, 0 hours n=10,9	47.6 μg/mL Geometric Coefficient of Variation 27.6	41.9 μg/mL Geometric Coefficient of Variation 44.7	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration Cycle 16, Day 1, 0 hours n=9,8	42.9 μg/mL Geometric Coefficient of Variation 39.4	47.0 μg/mL Geometric Coefficient of Variation 38.0	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration Cycle 1, Day 1, 0 hours n=29,28	0 μg/mL Geometric Coefficient of Variation 0	0 μg/mL Geometric Coefficient of Variation 0	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration Cycle 1, Day 1, end-of-infusion, n=27,27	53.5 μg/mL Geometric Coefficient of Variation 55.1	50.9 μg/mL Geometric Coefficient of Variation 36.0	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration Cycle 1, Day 1, 24 hours n=29,31	45.9 μg/mL Geometric Coefficient of Variation 23.6	43.7 μg/mL Geometric Coefficient of Variation 51.8	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration Cycle 1, Day 1, 168 hours n=28,29	21.5 μg/mL Geometric Coefficient of Variation 30.1	21.4 μg/mL Geometric Coefficient of Variation 42.2	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration Cycle 1, Day 1, 336 hours n=23,25	14.5 μg/mL Geometric Coefficient of Variation 33.8	14.9 μg/mL Geometric Coefficient of Variation 39.9	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration Cycle 2, Day 1, 0 hours n=19,25	11.5 μg/mL Geometric Coefficient of Variation 46.6	12.9 μg/mL Geometric Coefficient of Variation 39.3	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration Cycle 3, Day 1, 0 hours n=12,20	22.7 μg/mL Geometric Coefficient of Variation 39.8	20.6 μg/mL Geometric Coefficient of Variation 50.0	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration Cycle 4, Day 1, 0 hours n=12,20	24.7 μg/mL Geometric Coefficient of Variation 42.5	27.2 μg/mL Geometric Coefficient of Variation 55.0	—	—	—

SECONDARY outcome

Timeframe: Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)

Population: The pharmacokinetic (PK) analysis set -pemetrexed included all participants who received at least one dose of pemetrexed and had at least one evaluable PK sample for pemetrexed. Data are reported for the Part 1 Cohorts A and B arms only.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=9 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=11 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration Cycle 1, Day 1, Pre-infusion n=9,11	0 μg/mL Geometric Coefficient of Variation 0	517 μg/mL Geometric Coefficient of Variation 1.4	—	—	—
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration Cycle 1, Day 1, end-of-infusion, n=9,11	102000 μg/mL Geometric Coefficient of Variation 30.2	87800 μg/mL Geometric Coefficient of Variation 39.5	—	—	—
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration Cycle 1, Day 1, 1 hour n=9,11	39000 μg/mL Geometric Coefficient of Variation 23.3	39000 μg/mL Geometric Coefficient of Variation 29.5	—	—	—
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration Cycle 1, Day 1, 4 hours n=9,11	10300 μg/mL Geometric Coefficient of Variation 25.1	10300 μg/mL Geometric Coefficient of Variation 29.6	—	—	—
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration Cycle 1, Day 1, 8 hours n=9,11	3180 μg/mL Geometric Coefficient of Variation 38.3	2340 μg/mL Geometric Coefficient of Variation 58.8	—	—	—
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration Cycle 2, Day 1, Pre-infusion n=8,10	0 μg/mL Geometric Coefficient of Variation 0	0 μg/mL Geometric Coefficient of Variation 0	—	—	—
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration Cycle 2, Day 1, End-of-infusion n=9,10	93300 μg/mL Geometric Coefficient of Variation 19.0	92600 μg/mL Geometric Coefficient of Variation 37.5	—	—	—
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration Cycle 2, Day 1, 1 hour n=9,10	43600 μg/mL Geometric Coefficient of Variation 15.7	43500 μg/mL Geometric Coefficient of Variation 16.2	—	—	—
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration Cycle 2, Day 1, 2 hours n=9,9	26300 μg/mL Geometric Coefficient of Variation 19.1	23400 μg/mL Geometric Coefficient of Variation 13.9	—	—	—
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration Cycle 2, Day 1, 4 hours n=9,10	11100 μg/mL Geometric Coefficient of Variation 25.5	10800 μg/mL Geometric Coefficient of Variation 34.3	—	—	—
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration Cycle 2, Day 1, 8 hours n=9,10	3920 μg/mL Geometric Coefficient of Variation 39.1	2760 μg/mL Geometric Coefficient of Variation 55.0	—	—	—

SECONDARY outcome

Timeframe: Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=19 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=20 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Pemetrexed Concentration Cycle 1, Day 1, Pre-infusion n=18,18	0 μg/mL Geometric Coefficient of Variation 0	0 μg/mL Geometric Coefficient of Variation 0	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Pemetrexed Concentration Cycle 1, Day 1, end-of-infusion, n=19,20	92000 μg/mL Geometric Coefficient of Variation 21.9	86400 μg/mL Geometric Coefficient of Variation 46.6	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Pemetrexed Concentration Cycle 1, Day 1, 1 hour n=19,20	42900 μg/mL Geometric Coefficient of Variation 23.5	36900 μg/mL Geometric Coefficient of Variation 29.4	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Pemetrexed Concentration Cycle 1, Day 1, 4 hours n=19,20	11700 μg/mL Geometric Coefficient of Variation 33.3	9390 μg/mL Geometric Coefficient of Variation 48.5	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Pemetrexed Concentration Cycle 2, Day 1, Pre-infusion n=15,16	0 μg/mL Geometric Coefficient of Variation 0	0 μg/mL Geometric Coefficient of Variation 0	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Pemetrexed Concentration Cycle 2, Day 1, End-of-infusion n=15,17	89200 μg/mL Geometric Coefficient of Variation 40.8	97000 μg/mL Geometric Coefficient of Variation 32.3	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Pemetrexed Concentration Cycle 2, Day 1, 1 hour n=15,17	47600 μg/mL Geometric Coefficient of Variation 30.9	37300 μg/mL Geometric Coefficient of Variation 20.6	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Pemetrexed Concentration Cycle 2, Day 1, 2 hours n=15,17	26900 μg/mL Geometric Coefficient of Variation 28.7	20900 μg/mL Geometric Coefficient of Variation 41.9	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Pemetrexed Concentration Cycle 2, Day 1, 4 hours n=14,17	12500 μg/mL Geometric Coefficient of Variation 38.2	9880 μg/mL Geometric Coefficient of Variation 55.8	—	—	—

SECONDARY outcome

Timeframe: Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length =21 days)

Population: The pharmacokinetic (PK) analysis set -cisplatin included all participants who received at least one dose of cisplatin and had at least one evaluable PK sample for cisplatin. Data are reported for the Part 1 Cohort B arm only.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=11 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 1 (Safety Run-in): Plasma Cisplatin Concentration Cycle 1, Day 1, Pre-infusion n=11	0 μg/mL Geometric Coefficient of Variation 0	—	—	—	—
Part 1 (Safety Run-in): Plasma Cisplatin Concentration Cycle 1, Day 1, end-of-infusion, n=11	3750 μg/mL Geometric Coefficient of Variation 130.2	—	—	—	—
Part 1 (Safety Run-in): Plasma Cisplatin Concentration Cycle 1, Day 1, 2 hours n=6	3690 μg/mL Geometric Coefficient of Variation 248.2	—	—	—	—
Part 1 (Safety Run-in): Plasma Cisplatin Concentration Cycle 1, Day 1, 4 hours n=11	1930 μg/mL Geometric Coefficient of Variation 35.9	—	—	—	—
Part 1 (Safety Run-in): Plasma Cisplatin Concentration Cycle 1, Day 1, 8 hours n=11	1680 μg/mL Geometric Coefficient of Variation 22.4	—	—	—	—
Part 1 (Safety Run-in): Plasma Cisplatin Concentration Cycle 2, Day 1, Pre-infusion n=10	235 μg/mL Geometric Coefficient of Variation 29.3	—	—	—	—
Part 1 (Safety Run-in): Plasma Cisplatin Concentration Cycle 2, Day 1, End-of-infusion n=10	2900 μg/mL Geometric Coefficient of Variation 45.6	—	—	—	—
Part 1 (Safety Run-in): Plasma Cisplatin Concentration Cycle 2, Day 1, 1.5 hours n=10	2100 μg/mL Geometric Coefficient of Variation 51.9	—	—	—	—
Part 1 (Safety Run-in): Plasma Cisplatin Concentration Cycle 2, Day 1, 2 hours n=5	2650 μg/mL Geometric Coefficient of Variation 20.3	—	—	—	—
Part 1 (Safety Run-in): Plasma Cisplatin Concentration Cycle 2, Day 1, 8 hours n=10	1750 μg/mL Geometric Coefficient of Variation 29.9	—	—	—	—
Part 1 (Safety Run-in): Plasma Cisplatin Concentration Cycle 2, Day 1, 4 hours n=10	2070 μg/mL Geometric Coefficient of Variation 15.2	—	—	—	—

SECONDARY outcome

Timeframe: Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length = 21 days)

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=23 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=19 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Cisplatin Concentration Cycle 1, Day 1, Pre-infusion n=21,18	0 μg/mL Geometric Coefficient of Variation 0	177 μg/mL Geometric Coefficient of Variation 47.5	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Cisplatin Concentration Cycle 1, Day 1, end-of-infusion, n=20,18	3670 μg/mL Geometric Coefficient of Variation 49.6	3120 μg/mL Geometric Coefficient of Variation 20.9	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Cisplatin Concentration Cycle 1, Day 1, 2 hours n=17,18	2280 μg/mL Geometric Coefficient of Variation 27.8	2180 μg/mL Geometric Coefficient of Variation 23.5	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Cisplatin Concentration Cycle 1, Day 1, 4 hours n=17,16	1950 μg/mL Geometric Coefficient of Variation 11.2	1950 μg/mL Geometric Coefficient of Variation 17.5	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Cisplatin Concentration Cycle 2, Day 1, Pre-infusion n=20,14	288 μg/mL Geometric Coefficient of Variation 58.9	296 μg/mL Geometric Coefficient of Variation 51.7	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Cisplatin Concentration Cycle 2, Day 1, End-of-infusion n=19,13	3130 μg/mL Geometric Coefficient of Variation 92.0	2820 μg/mL Geometric Coefficient of Variation 88.2	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Cisplatin Concentration Cycle 2, Day 1, 1.5 hours n=16,12	2790 μg/mL Geometric Coefficient of Variation 29.9	2410 μg/mL Geometric Coefficient of Variation 38.3	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Cisplatin Concentration Cycle 2, Day 1, 2 hours n=16,12	2550 μg/mL Geometric Coefficient of Variation 22.7	2790 μg/mL Geometric Coefficient of Variation 23.9	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Cisplatin Concentration Cycle 2, Day 1, 4 hours n=19,11	2340 μg/mL Geometric Coefficient of Variation 17.4	2340 μg/mL Geometric Coefficient of Variation 13.7	—	—	—

SECONDARY outcome

Timeframe: Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)

Population: The pharmacokinetic (PK) analysis set -carboplatin included all participants who received at least one dose of carboplatin and had at least one evaluable PK sample for carboplatin. Data are reported for the Part 1 Cohorts A and C arms only.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=9 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=9 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 1 (Safety Run-in): Plasma Carboplatin Concentration Cycle 1, Day 1, Pre-infusion n=8,9	0 μg/mL Geometric Coefficient of Variation 0	0 μg/mL Geometric Coefficient of Variation 0	—	—	—
Part 1 (Safety Run-in): Plasma Carboplatin Concentration Cycle 1, Day 1, End-of-infusion, n=9,9	17400 μg/mL Geometric Coefficient of Variation 21.9	21700 μg/mL Geometric Coefficient of Variation 49.8	—	—	—
Part 1 (Safety Run-in): Plasma Carboplatin Concentration Cycle 1, Day 1, 1 hour n=9,6	10400 μg/mL Geometric Coefficient of Variation 42.7	13300 μg/mL Geometric Coefficient of Variation 46.8	—	—	—
Part 1 (Safety Run-in): Plasma Carboplatin Concentration Cycle 1, Day 1, 2 hours n=9,9	6200 μg/mL Geometric Coefficient of Variation 34.3	7380 μg/mL Geometric Coefficient of Variation 23.5	—	—	—
Part 1 (Safety Run-in): Plasma Carboplatin Concentration Cycle 1, Day 1, 4 hours n=9,9	3380 μg/mL Geometric Coefficient of Variation 34.6	3970 μg/mL Geometric Coefficient of Variation 29.4	—	—	—
Part 1 (Safety Run-in): Plasma Carboplatin Concentration Cycle 1, Day 1, 8 hours n=9,6	1370 μg/mL Geometric Coefficient of Variation 33.6	1540 μg/mL Geometric Coefficient of Variation 39.6	—	—	—
Part 1 (Safety Run-in): Plasma Carboplatin Concentration Cycle 2, Day 1, Pre-infusion n=9,9	125 μg/mL Geometric Coefficient of Variation 29.7	120 μg/mL Geometric Coefficient of Variation 16.4	—	—	—
Part 1 (Safety Run-in): Plasma Carboplatin Concentration Cycle 2, Day 1, End-of-infusion n=9,9	10300 μg/mL Geometric Coefficient of Variation 441.8	16200 μg/mL Geometric Coefficient of Variation 32.4	—	—	—
Part 1 (Safety Run-in): Plasma Carboplatin Concentration Cycle 2, Day 1, 1 hour n=8,6	13300 μg/mL Geometric Coefficient of Variation 44.1	11400 μg/mL Geometric Coefficient of Variation 24.5	—	—	—
Part 1 (Safety Run-in): Plasma Carboplatin Concentration Cycle 2, Day 1, 2 hours n=9,9	8080 μg/mL Geometric Coefficient of Variation 38.5	6620 μg/mL Geometric Coefficient of Variation 22.5	—	—	—
Part 1 (Safety Run-in): Plasma Carboplatin Concentration Cycle 2, Day 1, 4 hours n=9,9	3590 μg/mL Geometric Coefficient of Variation 26.8	3680 μg/mL Geometric Coefficient of Variation 26.7	—	—	—
Part 1 (Safety Run-in): Plasma Carboplatin Concentration Cycle 2, Day 1, 8 hours n=9,5	1670 μg/mL Geometric Coefficient of Variation 29.7	1800 μg/mL Geometric Coefficient of Variation 34.8	—	—	—

SECONDARY outcome

Timeframe: Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=18 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=23 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration Cycle 1, Day 1, Pre-infusion n=17,19	0 μg/mL Geometric Coefficient of Variation 0	668 μg/mL Geometric Coefficient of Variation 0	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration Cycle 1, Day 1, End-of-infusion, n=17,23	13800 μg/mL Geometric Coefficient of Variation 23.4	16900 μg/mL Geometric Coefficient of Variation 53.6	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration Cycle 1, Day 1, 1 hour n=14,21	9980 μg/mL Geometric Coefficient of Variation 40.4	10600 μg/mL Geometric Coefficient of Variation 35.9	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration Cycle 1, Day 1, 2 hours n=17,23	7250 μg/mL Geometric Coefficient of Variation 25.0	6930 μg/mL Geometric Coefficient of Variation 36.3	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration Cycle 1, Day 1, 4 hours n=16,22	3690 μg/mL Geometric Coefficient of Variation 26.4	3780 μg/mL Geometric Coefficient of Variation 46.7	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration Cycle 2, Day 1, Pre-infusion n=11,16	145 μg/mL Geometric Coefficient of Variation 37.2	121 μg/mL Geometric Coefficient of Variation 8.6	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration Cycle 2, Day 1, End-of-infusion n=11,18	14300 μg/mL Geometric Coefficient of Variation 34.8	13000 μg/mL Geometric Coefficient of Variation 183.5	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration Cycle 2, Day 1, 1 hour n=10,16	8880 μg/mL Geometric Coefficient of Variation 23.8	9490 μg/mL Geometric Coefficient of Variation 213.7	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration Cycle 2, Day 1, 2 hours n=12,18	6810 μg/mL Geometric Coefficient of Variation 35.3	7080 μg/mL Geometric Coefficient of Variation 26.5	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration Cycle 2, Day 1, 4 hours n=11,18	3990 μg/mL Geometric Coefficient of Variation 34.4	3830 μg/mL Geometric Coefficient of Variation 37.4	—	—	—

SECONDARY outcome

Timeframe: Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)

Population: The pharmacokinetic (PK) analysis set -paclitaxel included all participants who received at least one dose of paclitaxel and had at least one evaluable PK sample for paclitaxel. Data are reported for the Part 1 Cohort C arm only.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=9 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration Cycle 1, Day 1, Pre-infusion n=9	0 μg/mL Geometric Coefficient of Variation 0	—	—	—	—
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration Cycle 1, Day 1, End-of-infusion, n=9	4440 μg/mL Geometric Coefficient of Variation 42.5	—	—	—	—
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration Cycle 1, Day 1, 4 hours n=8	827 μg/mL Geometric Coefficient of Variation 111.3	—	—	—	—
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration Cycle 1, Day 1, 8 hours n=9	310 μg/mL Geometric Coefficient of Variation 83.5	—	—	—	—
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration Cycle 1, Day 1, 12 hours n=6	130 μg/mL Geometric Coefficient of Variation 78.3	—	—	—	—
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration Cycle 2, Day 1, Pre-infusion n=7	0 μg/mL Geometric Coefficient of Variation 0	—	—	—	—
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration Cycle 2, Day 1, End-of-infusion n=7	4940 μg/mL Geometric Coefficient of Variation 35.1	—	—	—	—
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration Cycle 2, Day 1, 4 hours n=7	1090 μg/mL Geometric Coefficient of Variation 89.5	—	—	—	—
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration Cycle 2, Day 1, 6 hours n=8	525 μg/mL Geometric Coefficient of Variation 74.1	—	—	—	—
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration Cycle 2, Day 1, 8 hours n=7	333 μg/mL Geometric Coefficient of Variation 79.8	—	—	—	—
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration Cycle 2, Day 1, 12 hours n=4	134 μg/mL Geometric Coefficient of Variation 89.7	—	—	—	—

SECONDARY outcome

Timeframe: Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=14 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=13 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Paclitaxel Concentration Cycle 1, Day 1, Pre-infusion n=12,11	0 μg/mL Geometric Coefficient of Variation 0	0 μg/mL Geometric Coefficient of Variation 0	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Paclitaxel Concentration Cycle 1, Day 1, End-of-infusion, n=13,12	4620 μg/mL Geometric Coefficient of Variation 97.3	3380 μg/mL Geometric Coefficient of Variation 116.8	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Paclitaxel Concentration Cycle 1, Day 1, 4 hours n=12,11	1880 μg/mL Geometric Coefficient of Variation 43.5	1900 μg/mL Geometric Coefficient of Variation 88.4	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Paclitaxel Concentration Cycle 1, Day 1, 24 hours n=10,8	102 μg/mL Geometric Coefficient of Variation 38.9	114 μg/mL Geometric Coefficient of Variation 47.4	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Paclitaxel Concentration Cycle 2, Day 1, Pre-infusion n=9,8	0 μg/mL Geometric Coefficient of Variation 0	0 μg/mL Geometric Coefficient of Variation 0	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Paclitaxel Concentration Cycle 2, Day 1, End-of-infusion n=10,9	3930 μg/mL Geometric Coefficient of Variation 41.8	3660 μg/mL Geometric Coefficient of Variation 75.1	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Paclitaxel Concentration Cycle 2, Day 1, 4 hours n=9,9	1450 μg/mL Geometric Coefficient of Variation 26.6	1180 μg/mL Geometric Coefficient of Variation 62.6	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Paclitaxel Concentration Cycle 2, Day 1, 6 hours n=7,8	920 μg/mL Geometric Coefficient of Variation 45.7	775 μg/mL Geometric Coefficient of Variation 55.0	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Paclitaxel Concentration Cycle 2, Day 1, 24 hours n=10,7	101 μg/mL Geometric Coefficient of Variation 23.6	81.4 μg/mL Geometric Coefficient of Variation 27.7	—	—	—

SECONDARY outcome

Timeframe: Predose (0 h) and end of infusion on Cy 1 and 2, 4, 8, 12 h post infusion on Cy 1, 4, 6, 8, 12 h post infusion on Cy 2 (Cy length =21 days)

Population: The pharmacokinetic (PK) analysis set -nab-paclitaxel included all participants who received at least one dose of nab-paclitaxel and had at least one evaluable PK sample for nab-paclitaxel. Data are reported for Part 2 only.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=11 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=15 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Nab-paclitaxel Concentration Cycle 1, Day 1, Pre-infusion n=9,13	0 μg/mL Geometric Coefficient of Variation 0	0 μg/mL Geometric Coefficient of Variation 0	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Nab-paclitaxel Concentration Cycle 1, Day 1, End-of-infusion, n=10,15	2620 μg/mL Geometric Coefficient of Variation 87.5	2520 μg/mL Geometric Coefficient of Variation 285.4	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Nab-paclitaxel Concentration Cycle 1, Day 1, 4 hours n=10,14	112 μg/mL Geometric Coefficient of Variation 38.3	117 μg/mL Geometric Coefficient of Variation 90.2	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Nab-paclitaxel Concentration Cycle 1, Day 1, 24 hours n=4,9	24.2 μg/mL Geometric Coefficient of Variation 16.7	23.9 μg/mL Geometric Coefficient of Variation 47.8	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Nab-paclitaxel Concentration Cycle 2, Day 1, Pre-infusion n=7,8	0 μg/mL Geometric Coefficient of Variation 0	44.6 μg/mL Geometric Coefficient of Variation 160.1	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Nab-paclitaxel Concentration Cycle 2, Day 1, End-of-infusion n=7,8	1630 μg/mL Geometric Coefficient of Variation 92.1	3440 μg/mL Geometric Coefficient of Variation 79.1	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Nab-paclitaxel Concentration Cycle 2, Day 1, 4 hours n=6,8	83.6 μg/mL Geometric Coefficient of Variation 45.5	96.5 μg/mL Geometric Coefficient of Variation 63.8	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Nab-paclitaxel Concentration Cycle 2, Day 1, 6 hours n=6,8	75.6 μg/mL Geometric Coefficient of Variation 47.1	86.1 μg/mL Geometric Coefficient of Variation 55.2	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Nab-paclitaxel Concentration Cycle 2, Day 1, 24 hours n=5,7	34.5 μg/mL Geometric Coefficient of Variation 107.7	23.6 μg/mL Geometric Coefficient of Variation 39.2	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 25 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, dyspnea, and chest pain). Scores for each scale and single-item range from 0 to 100, with higher scores indicating higher level of symptoms. TTDD for chest pain, cough and dyspnea was defined as the time from randomization to the date of event, which was defined as at least 10 points absolute worsening from baseline of the corresponding scale score, with no later change below this threshold ie.\<10 points was observed, or if this worsening was observed at the last assessment for the subject, or death due to any cause (whichever occurred earlier). If a subject did not have an event, TTDD was censored at the last adequate assessment.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=320 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=323 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive 10-point Deterioration (TTDD) Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire Chest Pain n=65,96	NA months The median and lower and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.	22.14 months Interval 18.4 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive 10-point Deterioration (TTDD) Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire Cough n=63,94	NA months The median and lower and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.	23.06 months Interval 17.51 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive 10-point Deterioration (TTDD) Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire Dyspnea n=111,149	19.61 months Interval 13.5 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	11.50 months Interval 7.66 to 15.9	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 25 months

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.

The European Organization for Research and Treatment of Cancer quality of life (EORTC QLQ-C30) is a questionnaire developed to assess the health-related quality of life of cancer participants. It assesses 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores range from 0 to 100. A high score for the functional or global health status scales indicates a high level of functioning or QoL; a high score for a symptom scale indicates a high level of symptoms.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=320 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=323 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive Deterioration in Global Health Status/Quality of Life, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire Quality of Life n=119, 129	17.54 months Interval 14.06 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	15.90 months Interval 11.4 to 20.04	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive Deterioration in Global Health Status/Quality of Life, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire Shortness of Breath n=83,115	NA months The median and lower and upper limits of 95% CI were not estimable due to an insufficient number of participants with events.	19.29 months Interval 14.13 to 21.62	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive Deterioration in Global Health Status/Quality of Life, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire Pain n=117,122	20.07 months Interval 13.24 to The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	17.91 months Interval 12.65 to 22.11	—	—	—

SECONDARY outcome

Timeframe: Assessed every 3 weeks from Week 3 through Week 108, at follow-up visits 1, 2, 3, 4, and 5 (follow-up visits occurred every 26 days from week 108), and at 7 and 28 days post-disease progression, all up to a maximum of 3.5 years

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.

The EQ-5D-5L questionnaire is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L measures 5 items on mobility, self-care, usual activities, pain/discomfort, anxiety/depression, measured on 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A utility index can be computed from the EQ 5D-5L descriptive system with utility scores ranging from -0.281 (worst imaginable health state) to 1 (best imaginable health state), with -0.281 representing an "unconscious" health state. A single index value is analyzed for the EQ-5D-5L score. An increase from baseline in the EQ-ED-5L utility index is indicative of an improvement.). CFB = change from baseline

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=320 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=323 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 3 n=254,249	0.766 score on a scale Standard Deviation 0.2138	0.768 score on a scale Standard Deviation 0.2153	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 6 n=236,230	0.029 score on a scale Standard Deviation 0.2135	0.032 score on a scale Standard Deviation 0.2317	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 9 n=220,219	0.019 score on a scale Standard Deviation 0.2074	0.059 score on a scale Standard Deviation 0.2512	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 12 n=192,214	0.028 score on a scale Standard Deviation 0.2101	0.044 score on a scale Standard Deviation 0.2486	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 15 n=194,196	0.031 score on a scale Standard Deviation 0.2103	0.039 score on a scale Standard Deviation 0.2512	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 18 n=187,198	0.020 score on a scale Standard Deviation 0.2192	0.050 score on a scale Standard Deviation 0.2723	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 21 n=173,176	0.016 score on a scale Standard Deviation 0.2291	0.041 score on a scale Standard Deviation 0.2533	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 24 n=160,164	0.027 score on a scale Standard Deviation 0.2062	0.050 score on a scale Standard Deviation 0.2824	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 27 n=157,155	0.020 score on a scale Standard Deviation 0.1929	0.043 score on a scale Standard Deviation 0.2828	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 30 n=140,145	0.047 score on a scale Standard Deviation 0.1928	0.046 score on a scale Standard Deviation 0.2897	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 33 n=136,124	0.036 score on a scale Standard Deviation 0.1996	0.055 score on a scale Standard Deviation 0.2595	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 36 n=129,119	0.061 score on a scale Standard Deviation 0.1767	0.054 score on a scale Standard Deviation 0.2881	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 39 n=133,119	0.037 score on a scale Standard Deviation 0.2015	0.071 score on a scale Standard Deviation 0.2816	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 42 n=124,102	0.044 score on a scale Standard Deviation 0.1794	0.063 score on a scale Standard Deviation 0.2680	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 45 n=124,100	0.035 score on a scale Standard Deviation 0.1961	0.065 score on a scale Standard Deviation 0.2584	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 48 n=111,105	0.056 score on a scale Standard Deviation 0.1870	0.081 score on a scale Standard Deviation 0.2603	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 51 n=103,95	0.026 score on a scale Standard Deviation 0.1682	0.067 score on a scale Standard Deviation 0.2840	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 54 n=104,90	0.043 score on a scale Standard Deviation 0.1703	0.054 score on a scale Standard Deviation 0.3086	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 57 n=109,86	0.037 score on a scale Standard Deviation 0.2012	0.049 score on a scale Standard Deviation 0.2979	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 60 n=94,84	0.022 score on a scale Standard Deviation 0.2119	0.069 score on a scale Standard Deviation 0.2819	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 63 n=94,76	0.034 score on a scale Standard Deviation 0.2056	0.082 score on a scale Standard Deviation 0.3043	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 66 n=89,79	0.026 score on a scale Standard Deviation 0.2011	0.071 score on a scale Standard Deviation 0.2996	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 69 n=93,74	0.052 score on a scale Standard Deviation 0.1805	0.061 score on a scale Standard Deviation 0.2964	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 72 n=87,70	0.032 score on a scale Standard Deviation 0.1890	0.057 score on a scale Standard Deviation 0.3176	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 75 n=78,69	0.021 score on a scale Standard Deviation 0.1797	0.080 score on a scale Standard Deviation 0.2966	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 78 n=77,64	0.027 score on a scale Standard Deviation 0.1979	0.056 score on a scale Standard Deviation 0.3064	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 81 n=73,61	0.035 score on a scale Standard Deviation 0.1844	0.042 score on a scale Standard Deviation 0.3529	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 84 n=63,59	0.056 score on a scale Standard Deviation 0.1923	0.064 score on a scale Standard Deviation 0.3125	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 87 n=44,43	0.049 score on a scale Standard Deviation 0.1894	0.057 score on a scale Standard Deviation 0.3474	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 90 n=37,30	0.050 score on a scale Standard Deviation 0.1610	0.039 score on a scale Standard Deviation 0.3502	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 93 n=24,24	0.082 score on a scale Standard Deviation 0.1861	0.074 score on a scale Standard Deviation 0.4112	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 96 n=19,14	0.071 score on a scale Standard Deviation 0.1604	0.018 score on a scale Standard Deviation 0.3986	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 99 n=15,9	0.116 score on a scale Standard Deviation 0.1755	0.099 score on a scale Standard Deviation 0.4211	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 102 n=8,4	0.144 score on a scale Standard Deviation 0.1730	-0.002 score on a scale Standard Deviation 0.4701	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 105 n=5,2	0.073 score on a scale Standard Deviation 0.1476	-0.232 score on a scale Standard Deviation 0.2489	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Week 108 n=1,0	0.121 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Efficacy Follow-up 1 n=9,10	-0.085 score on a scale Standard Deviation 0.2034	-0.153 score on a scale Standard Deviation 0.4494	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Efficacy Follow-up 2 n=2,4	-0.031 score on a scale Standard Deviation 0.6781	-0.195 score on a scale Standard Deviation 0.4873	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Efficacy Follow-up 3 n=2,1	0.406 score on a scale Standard Deviation 0.4349	0.163 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Efficacy Follow-up 4 n=0,1	—	0.292 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at CFB at Efficacy Follow-up 5 n=1,0	-0.144 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Post-disease Progression (7 days) n=32,24	-0.126 score on a scale Standard Deviation 0.2115	-0.048 score on a scale Standard Deviation 0.2844	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire CFB at Post-disease Progression (28 days) n=30,30	-0.031 score on a scale Standard Deviation 0.2191	-0.010 score on a scale Standard Deviation 0.2854	—	—	—

SECONDARY outcome

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.

The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status. CFB = change from baseline

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=320 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=323 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 3 n=254,249	0.1 score on a scale Standard Deviation 16.51	3.2 score on a scale Standard Deviation 18.35	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 6 n=236,230	1.3 score on a scale Standard Deviation 16.04	2.6 score on a scale Standard Deviation 18.18	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 9 n=220,219	1.4 score on a scale Standard Deviation 15.23	2.5 score on a scale Standard Deviation 17.22	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 12 n=192,214	0.0 score on a scale Standard Deviation 18.28	3.3 score on a scale Standard Deviation 16.78	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 15 n=194,196	0.8 score on a scale Standard Deviation 17.41	2.7 score on a scale Standard Deviation 18.72	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 18 n=187,198	0.4 score on a scale Standard Deviation 16.76	4.4 score on a scale Standard Deviation 17.66	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 21 n=173,176	0.0 score on a scale Standard Deviation 16.92	2.3 score on a scale Standard Deviation 18.49	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 24 n=161,164	0.4 score on a scale Standard Deviation 17.15	2.3 score on a scale Standard Deviation 19.40	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 27 n=158,155	0.1 score on a scale Standard Deviation 16.38	2.8 score on a scale Standard Deviation 17.65	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 30 n=141,145	0.7 score on a scale Standard Deviation 16.45	2.5 score on a scale Standard Deviation 19.08	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 33 n=137,124	0.8 score on a scale Standard Deviation 14.50	4.1 score on a scale Standard Deviation 17.00	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 36 n=130,119	2.3 score on a scale Standard Deviation 14.79	4.8 score on a scale Standard Deviation 16.73	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 39 n=134,119	2.2 score on a scale Standard Deviation 15.25	4.6 score on a scale Standard Deviation 16.68	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 42 n=125,103	1.5 score on a scale Standard Deviation 15.15	4.7 score on a scale Standard Deviation 17.17	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 45 n=125,100	1.2 score on a scale Standard Deviation 16.15	5.0 score on a scale Standard Deviation 14.75	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 48 n=112,105	0.9 score on a scale Standard Deviation 16.62	3.9 score on a scale Standard Deviation 17.29	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 51 n=104,95	0.8 score on a scale Standard Deviation 15.94	2.8 score on a scale Standard Deviation 17.07	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 54 n=104,90	0.5 score on a scale Standard Deviation 14.43	4.2 score on a scale Standard Deviation 17.50	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 57 n=110,86	0.2 score on a scale Standard Deviation 16.63	2.1 score on a scale Standard Deviation 19.12	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 60 n=95,84	-1.4 score on a scale Standard Deviation 16.49	2.8 score on a scale Standard Deviation 17.46	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 63 n=95,76	0.0 score on a scale Standard Deviation 17.35	3.0 score on a scale Standard Deviation 20.02	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 66 n=90,79	1.0 score on a scale Standard Deviation 15.49	4.6 score on a scale Standard Deviation 19.36	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 69 n=94,74	1.9 score on a scale Standard Deviation 15.48	5.6 score on a scale Standard Deviation 18.30	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 72 n=88,70	0.4 score on a scale Standard Deviation 15.30	3.6 score on a scale Standard Deviation 19.21	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 75 n=79,69	-0.1 score on a scale Standard Deviation 15.96	5.1 score on a scale Standard Deviation 19.12	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 78 n=78,64	0.1 score on a scale Standard Deviation 17.65	5.1 score on a scale Standard Deviation 19.34	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 81 n=73,61	0.2 score on a scale Standard Deviation 16.10	3.1 score on a scale Standard Deviation 19.38	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 84 n=64,59	2.0 score on a scale Standard Deviation 16.33	2.0 score on a scale Standard Deviation 19.05	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 87 n=44,43	0.6 score on a scale Standard Deviation 17.07	1.7 score on a scale Standard Deviation 18.35	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 90 n=37,30	-1.9 score on a scale Standard Deviation 17.04	2.6 score on a scale Standard Deviation 18.13	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 93 n=24,24	1.9 score on a scale Standard Deviation 16.06	0.7 score on a scale Standard Deviation 16.75	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 96 n=19,14	2.9 score on a scale Standard Deviation 15.01	4.8 score on a scale Standard Deviation 16.28	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 99 n=15,9	-1.2 score on a scale Standard Deviation 12.09	5.9 score on a scale Standard Deviation 19.51	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 102 n=8,4	5.3 score on a scale Standard Deviation 14.98	0.5 score on a scale Standard Deviation 21.63	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 105 n=5,2	7.2 score on a scale Standard Deviation 19.49	-15.5 score on a scale Standard Deviation 7.78	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Week 108 n=1,0	3.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Efficacy Follow-up 1 n=9,10	-1.6 score on a scale Standard Deviation 17.67	-9.8 score on a scale Standard Deviation 27.85	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Efficacy Follow-up 2 n=2,4	8.5 score on a scale Standard Deviation 9.19	-5.3 score on a scale Standard Deviation 17.23	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Efficacy Follow-up 3 n=2,1	12.5 score on a scale Standard Deviation 19.09	5.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Efficacy Follow-up 4 n=0,1	—	21.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at CFB at Efficacy Follow-up 5 n=1,0	0.0 score on a scale Standard Deviation NA Standard deviation was not calculable due the single data point for the mean value.	—	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Post-disease Progression (7 days) n=32,24	-10.4 score on a scale Standard Deviation 18.36	-4.6 score on a scale Standard Deviation 21.40	—	—	—
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS) CFB at Post-disease Progression (28 days) n=30,30	-0.1 score on a scale Standard Deviation 19.14	-1.4 score on a scale Standard Deviation 22.92	—	—	—

POST_HOC outcome

Timeframe: On-treatment deaths: Up to approximately 29 months in Part 1 or approximately 25 months in Part 2. Post-treatment survival follow-up deaths: Up to an additional 130 days.

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment.

On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from Day 31 after last dose of study medication to the data cut-off date.

Outcome measures

Outcome measures
Measure	Part 2: Canakinumab+Pembro+CTx n=10 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=11 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 1: Cohort C n=9 Participants Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Part 2: Canakinumab+Pembro+CTx n=320 Participants Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Part 2: Placebo+Pembro+CTx n=323 Participants Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
All Collected Deaths Post-treatment survival follow-up deaths	2 Participants	5 Participants	3 Participants	50 Participants	57 Participants
All Collected Deaths All deaths	6 Participants	6 Participants	7 Participants	147 Participants	159 Participants
All Collected Deaths Pre-treatment deaths	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
All Collected Deaths On-treatment deaths	4 Participants	1 Participants	4 Participants	97 Participants	102 Participants

Adverse Events

Part 1: Cohort A (On-treatment)

Serious events: 4 serious events

Other events: 10 other events

Deaths: 4 deaths

Part 1: Cohort B (On-treatment)

Serious events: 3 serious events

Other events: 11 other events

Deaths: 1 deaths

Part 1: Cohort C (On-treatment)

Serious events: 4 serious events

Other events: 9 other events

Deaths: 4 deaths

Part 2: Canakinumab+Pembro+CTx (On-treatment)

Serious events: 174 serious events

Other events: 309 other events

Deaths: 97 deaths

Part 2: Placebo+Pembro+CTx (On-treatment)

Serious events: 167 serious events

Other events: 310 other events

Deaths: 102 deaths

Part 1: Cohort A (Post-treatment Survival Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Part 1: Cohort B (Post-treatment Survival Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Part 1: Cohort C (Post-treatment Survival Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Part 2: Canakinumab+Pembro+CTx (Post-treatment Survival Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 50 deaths

Part 2: Placebo+Pembro+CTx (Post-treatment Survival Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 57 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Cohort A (On-treatment) n=10 participants at risk AEs during the on-treatment period (up to 30 days post-treatment)	Part 1: Cohort B (On-treatment) n=11 participants at risk AEs during the on-treatment period (up to 30 days post-treatment)	Part 1: Cohort C (On-treatment) n=9 participants at risk AEs during the on-treatment period (up to 30 days post-treatment)	Part 2: Canakinumab+Pembro+CTx (On-treatment) n=320 participants at risk AEs during the on-treatment period (up to 30 days post-treatment)	Part 2: Placebo+Pembro+CTx (On-treatment) n=322 participants at risk AEs during the on-treatment period (up to 30 days post-treatment)	Part 1: Cohort A (Post-treatment Survival Follow-up) Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.	Part 1: Cohort B (Post-treatment Survival Follow-up) Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.	Part 1: Cohort C (Post-treatment Survival Follow-up) Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.	Part 2: Canakinumab+Pembro+CTx (Post-treatment Survival Follow-up) Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.	Part 2: Placebo+Pembro+CTx (Post-treatment Survival Follow-up) Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
Blood and lymphatic system disorders Anaemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.1% 10/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.4% 11/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Blood and lymphatic system disorders Bicytopenia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Blood and lymphatic system disorders Coagulopathy	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.1% 10/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.5% 8/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Blood and lymphatic system disorders Granulocytopenia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Blood and lymphatic system disorders Immune-mediated cytopenia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Blood and lymphatic system disorders Leukopenia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Blood and lymphatic system disorders Neutropenia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.2% 7/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.5% 8/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Blood and lymphatic system disorders Pancytopenia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Acute myocardial infarction	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Angina pectoris	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Arrhythmia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Atrial fibrillation	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Atrial flutter	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Atrioventricular block complete	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Bradycardia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Cardiac arrest	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Cardiac failure	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Cardiac tamponade	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Cardio-respiratory arrest	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Cardiogenic shock	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Cardiovascular disorder	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Coronary artery stenosis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Myocardial infarction	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Myocarditis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Pericardial effusion	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Sinus bradycardia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Supraventricular tachycardia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Ventricular arrhythmia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Endocrine disorders Adrenal disorder	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Endocrine disorders Adrenal insufficiency	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Endocrine disorders Glucocorticoid deficiency	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Endocrine disorders Hypercalcaemia of malignancy	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Endocrine disorders Hyperthyroidism	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Endocrine disorders Hypophysitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Endocrine disorders Hypothyroidism	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Eye disorders Diplopia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Abdominal pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Autoimmune colitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Colitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Constipation	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.2% 7/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.1% 10/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Dysphagia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Enterocolitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Large intestine perforation	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Mesenteric artery thrombosis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Nausea	20.0% 2/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Odynophagia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Oesophageal haemorrhage	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Pancreatitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Stomatitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Vomiting	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Asthenia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Chest pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Condition aggravated	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Face oedema	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Fatigue	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Feeling abnormal	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders General physical health deterioration	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Generalised oedema	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Implant site pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Localised oedema	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Malaise	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Non-cardiac chest pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Oedema peripheral	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Performance status decreased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Pyrexia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.8% 12/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.5% 8/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Sudden death	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Hepatobiliary disorders Cholecystitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Hepatobiliary disorders Cholestasis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Hepatobiliary disorders Hepatic failure	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Hepatobiliary disorders Hepatitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Hepatobiliary disorders Hepatitis acute	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Immune system disorders Anaphylactic reaction	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Immune system disorders Anaphylactic shock	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Immune system disorders Hypersensitivity	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Abdominal infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Abscess limb	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Asymptomatic COVID-19	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Atypical pneumonia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Bacteraemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Bacterial sepsis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Biliary sepsis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations COVID-19	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations COVID-19 pneumonia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Cellulitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Dengue fever	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Empyema	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Escherichia bacteraemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Gastroenteritis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Gastroenteritis clostridial	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Gastrointestinal infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Gastrointestinal protozoal infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Herpes virus infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Infectious pleural effusion	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Influenza	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Klebsiella sepsis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Lower respiratory tract infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Lung abscess	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Meningitis aseptic	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Nasopharyngitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Neutropenic sepsis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Nosocomial infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Peritonitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Pneumonia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	10.0% 32/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	7.8% 25/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Pneumonia bacterial	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Pneumonia cytomegaloviral	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Pneumonia pseudomonal	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Pulmonary sepsis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Respiratory tract infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Sepsis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.1% 10/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Septic shock	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Skin infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Tracheobronchitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Urinary tract infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Urinary tract infection bacterial	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Urosepsis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Vascular device infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Wound infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Injury, poisoning and procedural complications Hip fracture	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Injury, poisoning and procedural complications Transfusion-related circulatory overload	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Alanine aminotransferase increased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Aspartate aminotransferase increased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Blood bilirubin increased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Blood creatine phosphokinase increased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Blood creatinine increased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Cortisol decreased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Eastern Cooperative Oncology Group performance status worsened	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Gamma-glutamyltransferase increased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Lipase increased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Lymphocyte count decreased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Neutrophil count decreased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Platelet count decreased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Transaminases increased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Troponin I increased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations White blood cell count decreased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Dehydration	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hypophagia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Malnutrition	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Necrotising myositis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Blast crisis in myelogenous leukaemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Altered state of consciousness	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Brain oedema	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Cerebellar infarction	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Cerebrovascular accident	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Cognitive disorder	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Diabetic neuropathy	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Diplegia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Dizziness	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Epilepsy	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Haemorrhage intracranial	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Hemianopia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Hemiparesis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Hypoaesthesia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Ischaemic stroke	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Neuropathy peripheral	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Polyneuropathy	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Presyncope	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Spinal cord compression	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Syncope	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Psychiatric disorders Confusional state	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Psychiatric disorders Delirium	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Psychiatric disorders Schizophrenia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Renal and urinary disorders Acute kidney injury	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Renal and urinary disorders Chronic kidney disease	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Renal and urinary disorders Haematuria	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Renal and urinary disorders Nephritis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Renal and urinary disorders Renal failure	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Renal and urinary disorders Renal impairment	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Renal and urinary disorders Ureteric obstruction	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Renal and urinary disorders Urinary retention	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Bronchial fistula	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.0% 16/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	4.0% 13/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Dyspnoea paroxysmal nocturnal	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Laryngeal obstruction	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.8% 9/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.5% 8/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.8% 9/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.5% 8/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Skin and subcutaneous tissue disorders Immune-mediated dermatitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Skin and subcutaneous tissue disorders Rash	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Arteriosclerosis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Deep vein thrombosis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Extremity necrosis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Hypertension	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Hypotension	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Jugular vein thrombosis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Thrombosis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Venous thrombosis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).

Other adverse events

Other adverse events
Measure	Part 1: Cohort A (On-treatment) n=10 participants at risk AEs during the on-treatment period (up to 30 days post-treatment)	Part 1: Cohort B (On-treatment) n=11 participants at risk AEs during the on-treatment period (up to 30 days post-treatment)	Part 1: Cohort C (On-treatment) n=9 participants at risk AEs during the on-treatment period (up to 30 days post-treatment)	Part 2: Canakinumab+Pembro+CTx (On-treatment) n=320 participants at risk AEs during the on-treatment period (up to 30 days post-treatment)	Part 2: Placebo+Pembro+CTx (On-treatment) n=322 participants at risk AEs during the on-treatment period (up to 30 days post-treatment)	Part 1: Cohort A (Post-treatment Survival Follow-up) Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.	Part 1: Cohort B (Post-treatment Survival Follow-up) Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.	Part 1: Cohort C (Post-treatment Survival Follow-up) Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.	Part 2: Canakinumab+Pembro+CTx (Post-treatment Survival Follow-up) Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.	Part 2: Placebo+Pembro+CTx (Post-treatment Survival Follow-up) Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
Blood and lymphatic system disorders Anaemia	30.0% 3/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	27.3% 3/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	33.3% 3/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	47.8% 153/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	46.0% 148/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Blood and lymphatic system disorders Leukopenia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	8.1% 26/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	4.7% 15/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Blood and lymphatic system disorders Neutropenia	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	38.8% 124/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	24.2% 78/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Blood and lymphatic system disorders Thrombocytopenia	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.1% 58/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	13.0% 42/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Atrial fibrillation	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Cardiac failure	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Palpitations	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Cardiac disorders Pericardial effusion	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Ear and labyrinth disorders Hypoacusis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	22.2% 2/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Ear and labyrinth disorders Tinnitus	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Endocrine disorders Hyperthyroidism	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	22.2% 2/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.9% 19/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	4.3% 14/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Endocrine disorders Hypothyroidism	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.7% 31/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	8.7% 28/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Eye disorders Conjunctivitis allergic	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Eye disorders Dry eye	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.2% 7/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Eye disorders Endocrine ophthalmopathy	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Eye disorders Glaucoma	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Eye disorders Lacrimation increased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	27.3% 3/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.8% 9/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.2% 7/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Eye disorders Vision blurred	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Eye disorders Visual impairment	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Eye disorders Xerophthalmia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Abdominal discomfort	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Abdominal distension	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Abdominal pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	27.3% 3/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	4.4% 14/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.9% 19/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Abdominal pain upper	20.0% 2/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.1% 10/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Anal incontinence	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Anal inflammation	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Constipation	60.0% 6/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	27.3% 3/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	22.2% 2/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	26.2% 84/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	25.2% 81/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Diarrhoea	30.0% 3/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	22.2% 2/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	19.1% 61/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	20.5% 66/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Dry mouth	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.1% 10/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Dyspepsia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.8% 9/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.8% 9/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.2% 7/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.8% 9/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Glossodynia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Haemorrhoidal haemorrhage	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Nausea	30.0% 3/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	45.5% 5/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	55.6% 5/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	35.9% 115/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	38.5% 124/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Odynophagia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Oesophageal pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Stomatitis	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.4% 11/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.3% 17/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Gastrointestinal disorders Vomiting	30.0% 3/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	45.5% 5/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	22.2% 2/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	16.9% 54/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	15.8% 51/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Asthenia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	27.3% 3/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	29.1% 93/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	27.0% 87/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Chest discomfort	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Chest pain	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.6% 18/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.6% 18/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Chills	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Effusion	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Fatigue	20.0% 2/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	45.5% 5/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	33.3% 3/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.4% 59/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	21.1% 68/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Generalised oedema	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.2% 7/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Injection site pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Injection site reaction	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Malaise	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.5% 8/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Mucosal inflammation	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.3% 17/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.3% 17/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Non-cardiac chest pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Oedema peripheral	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	10.9% 35/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	13.0% 42/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.8% 9/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.5% 8/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Peripheral swelling	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Pyrexia	20.0% 2/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	13.8% 44/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	20.2% 65/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Swelling	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
General disorders Swelling face	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Immune system disorders Allergic reaction to excipient	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Anal abscess	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Borrelia infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Candida infection	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Conjunctivitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.1% 10/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	4.0% 13/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Eye infection	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Fungal skin infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Nasopharyngitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	22.2% 2/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.2% 7/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Oral candidiasis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.5% 8/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Oral herpes	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Pharyngitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Pneumonia	20.0% 2/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	8.1% 26/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.0% 16/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Sinusitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Skin infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Upper respiratory tract infection	20.0% 2/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	27.3% 3/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.6% 18/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	4.7% 15/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Urinary tract infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.9% 19/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	6.2% 20/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Vaginal infection	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Infections and infestations Viral rhinitis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.5% 8/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Alanine aminotransferase increased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	23.8% 76/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	15.5% 50/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Amylase increased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	10.0% 32/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	12.1% 39/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Aspartate aminotransferase increased	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	19.4% 62/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	14.6% 47/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Blood alkaline phosphatase increased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	7.8% 25/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	6.8% 22/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Blood cholesterol increased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Blood creatinine increased	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	8.8% 28/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	13.0% 42/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Gamma-glutamyltransferase increased	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	15.3% 49/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.5% 37/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Lipase increased	20.0% 2/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.9% 19/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.6% 31/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Lymphocyte count decreased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	8.4% 27/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	4.3% 14/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Neutrophil count decreased	30.0% 3/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	27.3% 3/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	24.7% 79/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.0% 58/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Platelet count decreased	20.0% 2/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	15.6% 50/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.9% 32/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations SARS-CoV-2 test negative	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.2% 36/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	13.0% 42/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations Weight decreased	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.7% 31/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.3% 30/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Investigations White blood cell count decreased	20.0% 2/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	19.7% 63/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	13.4% 43/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Decreased appetite	30.0% 3/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	45.5% 5/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	28.4% 91/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	24.5% 79/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.2% 7/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hyperglycaemia	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	22.2% 2/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	7.5% 24/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	8.1% 26/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	6.2% 20/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.0% 16/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	10.3% 33/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.9% 32/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	7.8% 25/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	10.6% 34/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	7.5% 24/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.6% 18/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Metabolism and nutrition disorders Polydipsia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	36.4% 4/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	22.2% 2/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	15.3% 49/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	17.4% 56/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	8.1% 26/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.9% 32/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.5% 8/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.2% 7/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	22.2% 2/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.1% 10/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	4.1% 13/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.4% 11/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	27.3% 3/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	33.3% 3/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	7.8% 25/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	8.7% 28/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Neck pain	30.0% 3/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.8% 9/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	33.3% 3/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	6.9% 22/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	6.8% 22/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Musculoskeletal and connective tissue disorders Sjogren's syndrome	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to skin	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Dizziness	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	7.2% 23/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	6.5% 21/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Dysgeusia	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	4.7% 15/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.0% 16/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Headache	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	6.6% 21/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	10.2% 33/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Hypoaesthesia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.8% 9/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Neuropathy peripheral	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	44.4% 4/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	6.9% 22/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.6% 18/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Paraesthesia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	33.3% 3/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	7.5% 24/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	6.2% 20/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Peripheral sensory neuropathy	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Polyneuropathy	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Presyncope	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Nervous system disorders Taste disorder	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Psychiatric disorders Anxiety	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.4% 11/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.4% 11/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Psychiatric disorders Delirium	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Psychiatric disorders Insomnia	20.0% 2/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	22.2% 2/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 29/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.6% 31/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Psychiatric disorders Sleep disorder	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Renal and urinary disorders Acute kidney injury	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Renal and urinary disorders Dysuria	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.2% 7/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Renal and urinary disorders Nocturia	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Renal and urinary disorders Polyuria	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.93% 3/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Renal and urinary disorders Urinary retention	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Cough	40.0% 4/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	27.3% 3/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	16.9% 54/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	15.8% 51/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Dyspnoea	30.0% 3/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	36.4% 4/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	33.3% 3/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.4% 59/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.9% 61/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.8% 9/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.4% 11/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Haemoptysis	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.0% 16/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	6.8% 22/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.5% 8/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.1% 10/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Productive cough	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	5.0% 16/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	6.5% 21/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.5% 8/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Respiratory, thoracic and mediastinal disorders Tonsillar ulcer	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	22.2% 2/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 29/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.6% 31/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	4.7% 15/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	4.3% 14/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.2% 7/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	2.8% 9/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	15.0% 48/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	13.4% 43/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Skin and subcutaneous tissue disorders Rash	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	45.5% 5/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	22.2% 2/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	15.9% 51/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.9% 61/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.1% 10/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	3.1% 10/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Deep vein thrombosis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.6% 5/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Embolism	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.62% 2/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Haematoma	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.31% 1/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Hot flush	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.94% 3/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.2% 4/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Hypertension	10.0% 1/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	18.2% 2/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	11.1% 1/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	7.5% 24/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	6.8% 22/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Hypotension	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	4.1% 13/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	1.9% 6/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
Vascular disorders Subclavian vein thrombosis	0.00% 0/10 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	9.1% 1/11 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/9 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/320 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	0.00% 0/322 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).	— 0/0 • Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER