Trial Outcomes & Findings for DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] (NCT NCT03523585)

NCT ID: NCT03523585

Last Updated: 2025-11-14

Results Overview

Progression-free survival (PFS) by BICR was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 608 participants
• Primary outcome timeframe: Baseline up to 46 months postdose
• Results posted on: 2025-11-14

Participant Flow

A total of 608 participants were enrolled at study sites in 15 countries. Primary results reported is from first participant randomized up to data cut-off date of 30 Jun 2022. The results presented are based on primary analysis up to 46 months.

Participants in The Physician's Choice (TPC) group were randomized to 1 of the following 2 regimens: trastuzumab/capecitabine or lapatinib/capecitabine. As prespecified in the protocol, participants were assessed and reported separately per comparator arm for the disposition, baseline characteristics, and safety tables. For efficacy assessments, all participants in the TPC group were combined and assessed together.

Participant milestones

Measure	Trastuzumab Deruxtecan (T-DXd) Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).	Trastuzumab+Capecitabine Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine.	Lapatinib+Capecitabine Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Lapatinib/Capecitabine.
Overall Study STARTED	406	91	111
Overall Study Randomized	406	91	111
Overall Study Randomized But Not Treated	2	4	3
Overall Study COMPLETED	94	1	4
Overall Study NOT COMPLETED	312	90	107

Reasons for withdrawal

Measure	Trastuzumab Deruxtecan (T-DXd) Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).	Trastuzumab+Capecitabine Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine.	Lapatinib+Capecitabine Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Lapatinib/Capecitabine.
Overall Study Progressive Disease	174	64	77
Overall Study Adverse Event	74	5	9
Overall Study Withdrawal by Subject	30	11	6
Overall Study Clinical Progression	23	5	10
Overall Study Death	4	0	1
Overall Study Physician Decision	2	1	0
Overall Study Lost to Follow-up	1	0	0
Overall Study Miscellaneous	1	0	0
Overall Study Protocol Deviation	1	0	1
Overall Study Randomized But Not Treated	2	4	3

Baseline Characteristics

DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

Baseline characteristics by cohort

Measure	Trastuzumab Deruxtecan (T-DXd) n=406 Participants Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).	Trastuzumab+Capecitabine n=91 Participants Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine.	Lapatinib+Capecitabine n=111 Participants Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Lapatinib/Capecitabine.	Total n=608 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants
Age, Categorical Between 18 and 65 years	321 Participants n=10 Participants	73 Participants n=10 Participants	91 Participants n=20 Participants	485 Participants n=45 Participants
Age, Categorical >=65 years	85 Participants n=10 Participants	18 Participants n=10 Participants	20 Participants n=20 Participants	123 Participants n=45 Participants
Age, Continuous	54.6 years STANDARD_DEVIATION 11.99 • n=10 Participants	55.7 years STANDARD_DEVIATION 11.40 • n=10 Participants	54.6 years STANDARD_DEVIATION 11.06 • n=20 Participants	54.8 years STANDARD_DEVIATION 11.73 • n=45 Participants
Sex: Female, Male Female	403 Participants n=10 Participants	89 Participants n=10 Participants	111 Participants n=20 Participants	603 Participants n=45 Participants
Sex: Female, Male Male	3 Participants n=10 Participants	2 Participants n=10 Participants	0 Participants n=20 Participants	5 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	2 Participants n=45 Participants
Race (NIH/OMB) Asian	122 Participants n=10 Participants	20 Participants n=10 Participants	36 Participants n=20 Participants	178 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants	1 Participants n=45 Participants
Race (NIH/OMB) Black or African American	10 Participants n=10 Participants	2 Participants n=10 Participants	5 Participants n=20 Participants	17 Participants n=45 Participants
Race (NIH/OMB) White	257 Participants n=10 Participants	66 Participants n=10 Participants	61 Participants n=20 Participants	384 Participants n=45 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=10 Participants	3 Participants n=10 Participants	8 Participants n=20 Participants	26 Participants n=45 Participants
Region of Enrollment United States	41 participants n=10 Participants	14 participants n=10 Participants	9 participants n=20 Participants	64 participants n=45 Participants
Region of Enrollment Czechia	1 participants n=10 Participants	2 participants n=10 Participants	0 participants n=20 Participants	3 participants n=45 Participants
Region of Enrollment Japan	46 participants n=10 Participants	6 participants n=10 Participants	18 participants n=20 Participants	70 participants n=45 Participants
Region of Enrollment United Kingdom	27 participants n=10 Participants	4 participants n=10 Participants	4 participants n=20 Participants	35 participants n=45 Participants
Region of Enrollment Spain	29 participants n=10 Participants	8 participants n=10 Participants	7 participants n=20 Participants	44 participants n=45 Participants
Region of Enrollment Greece	9 participants n=10 Participants	3 participants n=10 Participants	2 participants n=20 Participants	14 participants n=45 Participants
Region of Enrollment South Korea	66 participants n=10 Participants	11 participants n=10 Participants	17 participants n=20 Participants	94 participants n=45 Participants
Region of Enrollment Turkey	36 participants n=10 Participants	12 participants n=10 Participants	4 participants n=20 Participants	52 participants n=45 Participants
Region of Enrollment Belgium	4 participants n=10 Participants	1 participants n=10 Participants	0 participants n=20 Participants	5 participants n=45 Participants
Region of Enrollment Brazil	41 participants n=10 Participants	10 participants n=10 Participants	8 participants n=20 Participants	59 participants n=45 Participants
Region of Enrollment Italy	33 participants n=10 Participants	3 participants n=10 Participants	17 participants n=20 Participants	53 participants n=45 Participants
Region of Enrollment Israel	14 participants n=10 Participants	0 participants n=10 Participants	4 participants n=20 Participants	18 participants n=45 Participants
Region of Enrollment France	37 participants n=10 Participants	8 participants n=10 Participants	12 participants n=20 Participants	57 participants n=45 Participants
Region of Enrollment Australia	10 participants n=10 Participants	7 participants n=10 Participants	4 participants n=20 Participants	21 participants n=45 Participants
Region of Enrollment Germany	12 participants n=10 Participants	2 participants n=10 Participants	5 participants n=20 Participants	19 participants n=45 Participants

PRIMARY outcome

Timeframe: Baseline up to 46 months postdose

Population: Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 30 Jun 2022.

Progression-free survival (PFS) by BICR was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause.

Outcome measures

Measure	Trastuzumab Deruxtecan (T-DXd) n=406 Participants Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).	Treatment of Investigator's/Physician's Choice (TPC) n=202 Participants Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine or Lapatinib/Capecitabine.
Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine	17.8 months Interval 14.3 to 20.8	6.9 months Interval 5.5 to 8.4

SECONDARY outcome

Timeframe: Baseline up to 46 months postdose

Population: Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 30 Jun 2022.

Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there is no death reported for a subject before the data cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive.

Outcome measures

Measure	Trastuzumab Deruxtecan (T-DXd) n=406 Participants Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).	Treatment of Investigator's/Physician's Choice (TPC) n=202 Participants Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine or Lapatinib/Capecitabine.
Overall Survival (OS) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine	39.2 months Interval 32.7 to Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.	26.5 months Interval 21.0 to Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.

SECONDARY outcome

Timeframe: Baseline up to 46 months postdose

Population: Objective response rate (ORR) was assessed in the Full Analysis Set at data cut-off date of 30 Jun 2022.

The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR and investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on BICR and Investigator Assessment is reported.

Outcome measures

Measure	Trastuzumab Deruxtecan (T-DXd) n=406 Participants Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).	Treatment of Investigator's/Physician's Choice (TPC) n=202 Participants Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine or Lapatinib/Capecitabine.
Percentage of Participants With Objective Response Rate (ORR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine BICR	69.7 Percentage of Participants Interval 65.0 to 74.1	29.2 Percentage of Participants Interval 23.0 to 36.0
Percentage of Participants With Objective Response Rate (ORR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine Investigator Assessment	74.1 Percentage of Participants Interval 69.6 to 78.3	26.7 Percentage of Participants Interval 20.8 to 33.4

SECONDARY outcome

Timeframe: Baseline up to 46 months postdose

Population: Duration of Response (DoR) was assessed in the Full Analysis Set of participants with confirmed CR/PR at data cut-off date of 30 Jun 2022.

Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on BICR and investigator assessment is reported.

Outcome measures

Measure	Trastuzumab Deruxtecan (T-DXd) n=283 Participants Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).	Treatment of Investigator's/Physician's Choice (TPC) n=59 Participants Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine or Lapatinib/Capecitabine.
Duration of Response (DoR) Based on BICR in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine	19.6 months Interval 15.9 to Upper CI was not estimable due to insufficient number of events.	8.3 months Interval 5.8 to 9.5

SECONDARY outcome

Timeframe: Up to 46 months

Population: Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 30 Jun 2022.

Progression-free survival (PFS) by investigator assessment was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause.

Outcome measures

Measure	Trastuzumab Deruxtecan (T-DXd) n=406 Participants Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).	Treatment of Investigator's/Physician's Choice (TPC) n=202 Participants Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine or Lapatinib/Capecitabine.
Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine	16.7 months Interval 14.3 to 19.6	5.5 months Interval 4.4 to 7.0

Adverse Events

Trastuzumab Deruxtecan (T-DXd)

Serious events: 103 serious events

Other events: 398 other events

Deaths: 143 deaths

Trastuzumab+Capecitabine

Serious events: 19 serious events

Other events: 79 other events

Deaths: 40 deaths

Lapatinib+Capecitabine

Serious events: 27 serious events

Other events: 102 other events

Deaths: 46 deaths

Serious adverse events

Measure	Trastuzumab Deruxtecan (T-DXd) n=404 participants at risk Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).	Trastuzumab+Capecitabine n=87 participants at risk Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine.	Lapatinib+Capecitabine n=108 participants at risk Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Lapatinib/Capecitabine.
Endocrine disorders Autoimmune Thyroiditis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Blood and lymphatic system disorders Anaemia	0.99% 4/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Blood and lymphatic system disorders Febrile Neutropenia	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Blood and lymphatic system disorders Haemolysis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Blood and lymphatic system disorders Pancytopenia	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Cardiac disorders Stress Cardiomyopathy	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Cardiac disorders Autoimmune Thyroiditis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Eye disorders Scleritis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Vomiting	1.5% 6/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	2.3% 2/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Nausea	1.2% 5/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	2.3% 2/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Diarrhoea	0.74% 3/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.4% 3/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Abdominal Pain	0.50% 2/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.4% 3/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Ascites	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Colitis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Duodenal Ulcer	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Faecaloma	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Gastritis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Large Intestinal Obstruction	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
General disorders Pyrexia	0.74% 3/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Oesophageal Varices Haemorrhage	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Stomatitis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
General disorders Fatigue	0.74% 3/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
General disorders Asthenia	0.50% 2/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
General disorders Disease Progression	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	2.8% 3/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
General disorders General Physical Health Deterioration	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
General disorders Non-Cardiac Chest Pain	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Covid-19	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Pneumonia	1.5% 6/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Covid-19 Pneumonia	0.50% 2/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Device Related Infection	0.50% 2/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Influenza	0.50% 2/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Pneumocystis Jirovecii Pneumonia	0.50% 2/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Urinary Tract Infection	0.50% 2/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Appendicitis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Cellulitis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Gastroenteritis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Hepatitis B	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Mastitis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Post Procedural Infection	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Pyelonephritis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Sepsis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Skin Infection	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Wound Infection	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Injury, poisoning and procedural complications Radiation Necrosis	0.50% 2/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Injury, poisoning and procedural complications Head Injury	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Injury, poisoning and procedural complications Hip Fracture	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Injury, poisoning and procedural complications Overdose	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Injury, poisoning and procedural complications Subdural Haematoma	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Injury, poisoning and procedural complications Wrist Fracture	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Metabolism and nutrition disorders Dehydration	0.99% 4/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Metabolism and nutrition disorders Decreased Appetite	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Metabolism and nutrition disorders Hypercalcaemia	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Metabolism and nutrition disorders Hypokalaemia	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Metabolism and nutrition disorders Hyponatraemia	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Arthralgia	0.50% 2/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Neck Pain	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Osteonecrosis Of Jaw	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukaemia	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Pleural Effusion	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Meninges	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Ovary	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pulmonary Tumour Thrombotic Microangiopathy	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Brain Oedema	0.50% 2/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Depressed Level Of Consciousness	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Dizziness	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Epilepsy	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Generalised Tonic-Clonic Seizure	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Headache	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Hemiplegia	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Monoplegia	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Seizure	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Syncope	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Vasogenic Cerebral Oedema	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Psychiatric disorders Depression	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Psychiatric disorders Mental Status Changes	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Psychiatric disorders Suicide Attempt	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Renal and urinary disorders Acute Kidney Injury	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Renal and urinary disorders Cystitis Haemorrhagic	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Reproductive system and breast disorders Breast Pain	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.5% 10/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Vascular disorders Haemorrhage	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.74% 3/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.50% 2/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	2.8% 3/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Laryngeal Haemorrhage	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Lung Disorder	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Pulmonary Haemorrhage	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Vascular disorders Brachiocephalic Vein Thrombosis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Vascular disorders Deep Vein Thrombosis	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Vascular disorders Lymphoedema	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Vascular disorders Orthostatic Hypotension	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Constipation	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Abdominal Sepsis	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Gingivitis	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Neutropenic Sepsis	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Injury, poisoning and procedural complications Accidental Overdose	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Cerebral Ischaemia	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Vascular disorders Embolism	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Cardiac disorders Cardiac Arrest	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Cardiac disorders Cardiac Failure	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Cardiac disorders Myocardial Ischaemia	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Cardiac disorders Pericardial Effusion	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Gastric Antral Vascular Ectasia	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Haematemesis	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Peritonitis Bacterial	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Respiratory Tract Infection	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Injury, poisoning and procedural complications Craniocerebral Injury	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Investigations Hepatic Enzyme Increased	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Investigations Pancreatic Enzymes Increased	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Vascular disorders Hypertensive Urgency	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Vascular disorders Hypotension	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Vascular disorders Peripheral Ischaemia	0.00% 0/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.

Other adverse events

Measure	Trastuzumab Deruxtecan (T-DXd) n=404 participants at risk Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).	Trastuzumab+Capecitabine n=87 participants at risk Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine.	Lapatinib+Capecitabine n=108 participants at risk Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Lapatinib/Capecitabine.
Blood and lymphatic system disorders Anaemia	28.2% 114/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	14.9% 13/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	12.0% 13/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Blood and lymphatic system disorders Neutropenia	16.1% 65/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 4/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	5.6% 6/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Blood and lymphatic system disorders Thrombocytopenia	10.1% 41/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 4/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	6.5% 7/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Blood and lymphatic system disorders Leukopenia	5.7% 23/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	2.3% 2/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.9% 2/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Blood and lymphatic system disorders Lymphopenia	5.2% 21/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Eye disorders Dry Eye	5.7% 23/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 4/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 5/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Nausea	72.3% 292/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	33.3% 29/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	40.7% 44/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Vomiting	37.1% 150/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	10.3% 9/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	13.0% 14/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Constipation	35.1% 142/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	13.8% 12/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	8.3% 9/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Diarrhoea	27.0% 109/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	37.9% 33/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	63.9% 69/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Dyspepsia	11.9% 48/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	6.9% 6/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	11.1% 12/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Abdominal Pain	11.1% 45/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	8.0% 7/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	10.2% 11/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Stomatitis	10.9% 44/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	12.6% 11/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	23.1% 25/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Gastrointestinal disorders Abdominal Pain Upper	9.4% 38/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	8.0% 7/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	10.2% 11/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
General disorders Fatigue	35.6% 144/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	23.0% 20/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	29.6% 32/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
General disorders Asthenia	24.0% 97/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	6.9% 6/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	12.0% 13/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
General disorders Pyrexia	12.6% 51/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	5.7% 5/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	6.5% 7/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
General disorders Oedema Peripheral	6.7% 27/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 4/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 5/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
General disorders Mucosal Inflammation	3.7% 15/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	6.9% 6/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	8.3% 9/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Covid-19	11.6% 47/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.9% 2/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Urinary Tract Infection	8.4% 34/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.4% 3/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	2.8% 3/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Nasopharyngitis	5.2% 21/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.4% 3/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.9% 2/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Upper Respiratory Tract Infection	5.2% 21/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.4% 3/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	2.8% 3/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Infections and infestations Paronychia	2.5% 10/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.4% 3/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	10.2% 11/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Investigations Neutrophil Count Decreased	19.6% 79/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	8.0% 7/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	6.5% 7/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Investigations Weight Decreased	17.6% 71/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	2.3% 2/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 5/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Investigations Aspartate Aminotransferase Increased	16.3% 66/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	5.7% 5/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	16.7% 18/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Investigations Alanine Aminotransferase Increased	15.1% 61/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	6.9% 6/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	13.0% 14/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Investigations White Blood Cell Count Decreased	14.6% 59/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	5.7% 5/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.7% 4/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Investigations Platelet Count Decreased	12.1% 49/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	5.7% 5/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	6.5% 7/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Investigations Lymphocyte Count Decreased	7.4% 30/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	2.3% 2/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.9% 2/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Investigations Blood Alkaline Phosphatase Increased	5.9% 24/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 4/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.7% 4/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Investigations Blood Bilirubin Increased	5.0% 20/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 4/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	15.7% 17/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Metabolism and nutrition disorders Decreased Appetite	30.7% 124/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	17.2% 15/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	18.5% 20/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Metabolism and nutrition disorders Hypokalaemia	6.9% 28/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	8.0% 7/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	5.6% 6/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Arthralgia	10.4% 42/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	8.0% 7/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	6.5% 7/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Back Pain	8.9% 36/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 5/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Pain In Extremity	5.9% 24/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 4/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.7% 4/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Myalgia	5.7% 23/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 4/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.7% 4/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Muscle Spasms	3.2% 13/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 4/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	6.5% 7/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Headache	19.6% 79/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	8.0% 7/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 5/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Dysgeusia	8.2% 33/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.4% 3/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.93% 1/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Dizziness	7.9% 32/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	5.7% 5/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	8.3% 9/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Nervous system disorders Neuropathy Peripheral	3.0% 12/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	6.9% 6/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.7% 4/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Psychiatric disorders Insomnia	6.2% 25/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	6.9% 6/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 5/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Cough	13.1% 53/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	8.0% 7/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	12.0% 13/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.2% 33/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.4% 3/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	9.3% 10/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.2% 33/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	5.7% 5/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	6.5% 7/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Pneumonitis	6.2% 25/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Skin and subcutaneous tissue disorders Alopecia	37.1% 150/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	4.6% 4/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.7% 4/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Skin and subcutaneous tissue disorders Rash	6.7% 27/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.4% 3/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	17.6% 19/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Skin and subcutaneous tissue disorders Pruritus	5.4% 22/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	2.3% 2/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	5.6% 6/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Skin and subcutaneous tissue disorders Dry Skin	2.7% 11/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	3.4% 3/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	5.6% 6/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysaesthesia Syndrome	1.7% 7/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	55.2% 48/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	48.1% 52/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	1.5% 6/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	2.3% 2/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	5.6% 6/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Skin and subcutaneous tissue disorders Dermatitis Acneiform	0.50% 2/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	0.00% 0/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	9.3% 10/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.
Skin and subcutaneous tissue disorders Skin Toxicity	0.25% 1/404 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	1.1% 1/87 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.	5.6% 6/108 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 1-908-992-6400

Email: CTRinfo@dsi.com

Results disclosure agreements

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