Trial Outcomes & Findings for Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (NCT NCT04162210)

NCT ID: NCT04162210

Last Updated: 2026-02-11

Results Overview

PFS is time from randomization until earliest date of progressive disease (PD), or death due to any cause per investigator-assessed response per IMWG. PD is ≥25% increase from nadir in any of following: serum M-protein (absolute increase ≥0.5 gram per deciliter \[g/dL\]),urine M-protein(absolute increase ≥200 mg/24hr),difference between involved/uninvolved FLC levels (absolute increase \>10 mg/dL) in patients without measurable serum and urine M-protein levels, or bone marrow plasma-cell percentage irrespective of baseline status (absolute increase ≥10%) in patients without measurable serum and urine M-protein levels and without measurable involved FLC levels; appearance of new lesion,≥50% increase in longest diameter of a lesion previously measured \>1cm in short axis, or ≥50% increase from nadir in sum of products of two longest perpendicular diameters of more than 1 lesion; ≥50% increase in circulating plasma cells (minimum of 200 cells/microliter) if this is only measure of disease.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 325 participants
• Primary outcome timeframe: Up to 27 months
• Results posted on: 2026-02-11

Participant Flow

The results presented are based on the primary analysis (and includes data up to a maximum of 27 months). Data collection is still ongoing and additional results will be provided after study completion.

Participant milestones

Measure	Belantamab Mafodotin Participants with relapsed/refractory multiple myeloma (RRMM) received at least 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle up to approximately 23 months.	Pomalidomide Plus Dexamethasone Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22) up to approximately 24 months.
Overall Study STARTED	218	107
Overall Study Safety Population	217	102
Overall Study COMPLETED	84	38
Overall Study NOT COMPLETED	134	69

Reasons for withdrawal

Measure	Belantamab Mafodotin Participants with relapsed/refractory multiple myeloma (RRMM) received at least 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle up to approximately 23 months.	Pomalidomide Plus Dexamethasone Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22) up to approximately 24 months.
Overall Study Lost to Follow-up	4	1
Overall Study Withdrawal by Subject	17	9
Overall Study Ongoing	113	59

Baseline Characteristics

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Baseline characteristics by cohort

Measure	Belantamab Mafodotin n=218 Participants Participants with relapsed/refractory multiple myeloma (RRMM) received at least 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle up to approximately 23 months.	Pomalidomide Plus Dexamethasone n=107 Participants Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22) up to approximately 24 months.	Total n=325 Participants Total of all reporting groups
Age, Continuous	66.3 YEARS STANDARD_DEVIATION 9.67 • n=4 Participants	66.6 YEARS STANDARD_DEVIATION 9.68 • n=4 Participants	66.4 YEARS STANDARD_DEVIATION 9.66 • n=8 Participants
Sex: Female, Male Female	100 Participants n=4 Participants	41 Participants n=4 Participants	141 Participants n=8 Participants
Sex: Female, Male Male	118 Participants n=4 Participants	66 Participants n=4 Participants	184 Participants n=8 Participants
Race/Ethnicity, Customized Asian	47 Participants n=4 Participants	19 Participants n=4 Participants	66 Participants n=8 Participants
Race/Ethnicity, Customized Black Or African American	3 Participants n=4 Participants	1 Participants n=4 Participants	4 Participants n=8 Participants
Race/Ethnicity, Customized White	162 Participants n=4 Participants	84 Participants n=4 Participants	246 Participants n=8 Participants
Race/Ethnicity, Customized Not Reported	6 Participants n=4 Participants	3 Participants n=4 Participants	9 Participants n=8 Participants

PRIMARY outcome

Timeframe: Up to 27 months

Population: Intent-to-treat population included all randomized participants whether or not randomized treatment was administered.

PFS is time from randomization until earliest date of progressive disease (PD), or death due to any cause per investigator-assessed response per IMWG. PD is ≥25% increase from nadir in any of following: serum M-protein (absolute increase ≥0.5 gram per deciliter [g/dL]),urine M-protein(absolute increase ≥200 mg/24hr),difference between involved/uninvolved FLC levels (absolute increase >10 mg/dL) in patients without measurable serum and urine M-protein levels, or bone marrow plasma-cell percentage irrespective of baseline status (absolute increase ≥10%) in patients without measurable serum and urine M-protein levels and without measurable involved FLC levels; appearance of new lesion,≥50% increase in longest diameter of a lesion previously measured >1cm in short axis, or ≥50% increase from nadir in sum of products of two longest perpendicular diameters of more than 1 lesion; ≥50% increase in circulating plasma cells (minimum of 200 cells/microliter) if this is only measure of disease.

Outcome measures

Measure	Belantamab Mafodotin n=218 Participants Participants with relapsed/refractory multiple myeloma (RRMM) received at least 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle up to approximately 23 months.	Pomalidomide Plus Dexamethasone n=107 Participants Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22) up to approximately 24 months.
Progression-free Survival (PFS) Based on Investigator-assessed Response as Per International Myeloma Working Group (IMWG)	11.2 Months Interval 6.4 to 14.5	7.0 Months Interval 4.6 to 10.6

SECONDARY outcome

Timeframe: 60 months

OS is defined as the time from randomization until death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

ORR is defined as the percentage of participants with a confirmed partial response (PR) or better per IMWG.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

CBR is defined as the percentage of participants with a confirmed minimal response (MR) or better per IMWG.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

DoR is defined as the time from first documented evidence of PR or better until progressive disease (PD) per IMWG or death due to PD among participants who achieve confirmed PR or better.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

TTP is defined as the time from the date of randomization until the earliest date of documented PD (per IMWG Response Criteria) or death due to PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Blood samples will be collected for the analysis of hematology parameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Blood samples will be collected for the analysis of hematology parameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Blood samples will be collected for the analysis of hematology parameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Blood samples will be collected for the analysis of hematology parameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Blood samples will be collected for the analysis of hematology parameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Blood samples will be collected for the analysis of hematology parameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Blood samples will be collected for the analysis of clinical chemistry parameters like ALT, AST, ALP, CK, GGT, and LDH [International units per Liter

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Blood samples will be collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Blood samples will be collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Blood samples will be collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Urine samples will be collected for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Urine samples will be collected for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Urine samples will be collected for the assessment of urinary glucose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Urine samples will be collected for the assessment of urinary protein.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Urine samples will be collected for the assessment of urinary ketones.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Urine samples will be collected for the assessment of urinary blood.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 55 months

Urine samples will be collected for the assessment of urinary creatinine/albumin ratio.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

Participants will be assessed for any abnormal ocular findings.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

Blood samples will be collected for the analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

Blood samples will be collected for the analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

Blood samples will be collected for the analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

Blood samples will be collected for the analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

Blood samples will be collected for the analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

OSDI is a 12-item questionnaire designed to assesses both the frequency of dry eye symptoms and their impact on vision-related functioning. It is graded on a scale of 0-4, with 0 indicating none of the time, 1 for some of the time, 2 for half of the time, 3 for most of the time and 4 indicating all the time. A higher score represents greater symptoms severity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. For the EORTC IL52, disease symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score represents a high/healthy level of functioning.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 55 months

MRD negativity rate, defined as; the percentage of participants who are MRD negative by Next generation sequencing (NGS) method.

Outcome measures

Outcome data not reported

Adverse Events

Belantamab Mafodotin

Serious events: 94 serious events

Other events: 200 other events

Deaths: 83 deaths

Pomalidomide Plus Dexamethasone

Serious events: 40 serious events

Other events: 88 other events

Deaths: 38 deaths

Serious adverse events

Measure	Belantamab Mafodotin n=217 participants at risk Participants with relapsed/refractory multiple myeloma (RRMM) received at least 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle up to approximately 23 months.	Pomalidomide Plus Dexamethasone n=102 participants at risk Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22) up to approximately 24 months.
Infections and infestations Pneumonia	2.8% 6/217 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	7.8% 8/102 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations COVID-19	2.3% 5/217 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	2.9% 3/102 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Septic shock	1.4% 3/217 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Urinary tract infection	1.4% 3/217 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations COVID-19 pneumonia	0.92% 2/217 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	4.9% 5/102 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Lower respiratory tract infection	0.92% 2/217 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Osteomyelitis	0.92% 2/217 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Sepsis	0.92% 2/217 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	2.9% 3/102 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Cellulitis	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Pneumonia influenzal	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Pneumonia pneumococcal	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Postoperative wound infection	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Pseudomembranous colitis	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Respiratory tract infection	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Rhinovirus infection	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Spontaneous bacterial peritonitis	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Upper respiratory tract infection	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Arthritis infective	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Coronavirus infection	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Cytomegalovirus infection	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Diverticulitis	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Influenza	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Neutropenic sepsis	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Perineal abscess	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Pulmonary nocardiosis	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Sinusitis	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Blood and lymphatic system disorders Thrombocytopenia	3.7% 8/217 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Blood and lymphatic system disorders Anaemia	2.3% 5/217 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Blood and lymphatic system disorders Febrile neutropenia	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	4.9% 5/102 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Blood and lymphatic system disorders Lymphadenopathy	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Blood and lymphatic system disorders Neutropenia	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Blood and lymphatic system disorders Myelosuppression	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Injury, poisoning and procedural complications Infusion related reaction	1.8% 4/217 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Injury, poisoning and procedural complications Fall	1.4% 3/217 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Injury, poisoning and procedural complications Femur fracture	0.92% 2/217 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Injury, poisoning and procedural complications Clavicle fracture	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Injury, poisoning and procedural complications Dislocation of vertebra	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Injury, poisoning and procedural complications Hip fracture	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Injury, poisoning and procedural complications Road traffic accident	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Injury, poisoning and procedural complications Subdural haematoma	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Musculoskeletal and connective tissue disorders Pathological fracture	1.4% 3/217 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Musculoskeletal and connective tissue disorders Bone pain	0.92% 2/217 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Musculoskeletal and connective tissue disorders Back pain	0.46% 1/217 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Musculoskeletal and connective tissue disorders Myopathy	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Nervous system disorders Spinal cord compression	1.4% 3/217 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Nervous system disorders Cauda equina syndrome	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Nervous system disorders Cerebral haemorrhage	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Nervous system disorders Encephalopathy	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Nervous system disorders Epilepsy	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Nervous system disorders Haemorrhagic stroke	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Nervous system disorders Hyperammonaemic encephalopathy	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Nervous system disorders Peripheral motor neuropathy	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Nervous system disorders Radicular pain	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Nervous system disorders Transient global amnesia	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Nervous system disorders Transient ischaemic attack	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	1.4% 3/217 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal cord neoplasm	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Cardiac disorders Atrial fibrillation	0.92% 2/217 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Cardiac disorders Cardiac failure	0.92% 2/217 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Cardiac disorders Angina pectoris	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Cardiac disorders Cardio-respiratory arrest	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Cardiac disorders Acute myocardial infarction	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Cardiac disorders Cardiac arrest	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Cardiac disorders Cardiac failure congestive	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.92% 2/217 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Gastrointestinal disorders Vomiting	0.92% 2/217 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Gastrointestinal disorders Abdominal compartment syndrome	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Gastrointestinal disorders Colitis	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Gastrointestinal disorders Gastric haemorrhage	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Gastrointestinal disorders Haematochezia	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Gastrointestinal disorders Small intestinal haemorrhage	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Gastrointestinal disorders Inguinal hernia	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
General disorders Pyrexia	3.2% 7/217 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Investigations Platelet count decreased	1.8% 4/217 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Investigations Neutrophil count decreased	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Investigations Alanine aminotransferase increased	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.92% 2/217 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Renal and urinary disorders Acute kidney injury	0.92% 2/217 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Renal and urinary disorders Haematuria	0.92% 2/217 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Renal and urinary disorders Renal failure	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Vascular disorders Deep vein thrombosis	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Vascular disorders Hypertensive crisis	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Vascular disorders Shock haemorrhagic	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Metabolism and nutrition disorders Hypercalcaemia	0.92% 2/217 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Endocrine disorders Adrenal insufficiency	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Hepatobiliary disorders Cholecystitis acute	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Immune system disorders Cytokine release syndrome	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Product Issues Device extrusion	0.00% 0/217 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Psychiatric disorders Confusional state	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Skin and subcutaneous tissue disorders Angioedema	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Social circumstances Loss of personal independence in daily activities	0.46% 1/217 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.

Other adverse events

Measure	Belantamab Mafodotin n=217 participants at risk Participants with relapsed/refractory multiple myeloma (RRMM) received at least 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle up to approximately 23 months.	Pomalidomide Plus Dexamethasone n=102 participants at risk Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22) up to approximately 24 months.
Blood and lymphatic system disorders Thrombocytopenia	32.3% 70/217 • Number of events 98 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	30.4% 31/102 • Number of events 61 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Blood and lymphatic system disorders Anaemia	28.1% 61/217 • Number of events 78 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	29.4% 30/102 • Number of events 37 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Blood and lymphatic system disorders Neutropenia	11.1% 24/217 • Number of events 47 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	38.2% 39/102 • Number of events 86 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Blood and lymphatic system disorders Leukopenia	3.2% 7/217 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	8.8% 9/102 • Number of events 19 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Blood and lymphatic system disorders Lymphopenia	2.3% 5/217 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	6.9% 7/102 • Number of events 24 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Eye disorders Vision blurred	39.6% 86/217 • Number of events 172 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	2.0% 2/102 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Eye disorders Dry eye	28.1% 61/217 • Number of events 116 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	2.0% 2/102 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Eye disorders Foreign body sensation in eyes	26.3% 57/217 • Number of events 129 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	2.0% 2/102 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Eye disorders Eye irritation	23.0% 50/217 • Number of events 87 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Eye disorders Photophobia	21.2% 46/217 • Number of events 64 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Eye disorders Visual acuity reduced	18.9% 41/217 • Number of events 97 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Eye disorders Eye pain	16.1% 35/217 • Number of events 54 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Eye disorders Keratopathy	12.0% 26/217 • Number of events 29 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Eye disorders Punctate keratitis	10.6% 23/217 • Number of events 44 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Eye disorders Visual impairment	6.0% 13/217 • Number of events 25 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Eye disorders Cataract	5.5% 12/217 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	4.9% 5/102 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Eye disorders Keratitis	5.5% 12/217 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Investigations Blood lactate dehydrogenase increased	15.2% 33/217 • Number of events 37 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Investigations Aspartate aminotransferase increased	13.8% 30/217 • Number of events 32 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	4.9% 5/102 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Investigations Platelet count decreased	12.4% 27/217 • Number of events 32 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	11.8% 12/102 • Number of events 19 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Investigations Gamma-glutamyltransferase increased	10.1% 22/217 • Number of events 24 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	4.9% 5/102 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Investigations Neutrophil count decreased	7.8% 17/217 • Number of events 35 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	13.7% 14/102 • Number of events 34 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Investigations Alanine aminotransferase increased	6.5% 14/217 • Number of events 16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	7.8% 8/102 • Number of events 17 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Investigations White blood cell count decreased	5.5% 12/217 • Number of events 19 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	8.8% 9/102 • Number of events 21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Investigations Blood creatinine increased	4.6% 10/217 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	5.9% 6/102 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Investigations Lymphocyte count decreased	3.7% 8/217 • Number of events 15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	5.9% 6/102 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
General disorders Pyrexia	15.7% 34/217 • Number of events 47 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	8.8% 9/102 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
General disorders Fatigue	8.3% 18/217 • Number of events 19 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	14.7% 15/102 • Number of events 15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
General disorders Chills	6.0% 13/217 • Number of events 16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
General disorders Oedema peripheral	2.8% 6/217 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	9.8% 10/102 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Gastrointestinal disorders Nausea	11.5% 25/217 • Number of events 32 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	3.9% 4/102 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Gastrointestinal disorders Diarrhoea	10.1% 22/217 • Number of events 27 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	10.8% 11/102 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Gastrointestinal disorders Vomiting	7.4% 16/217 • Number of events 22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.98% 1/102 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Gastrointestinal disorders Constipation	5.5% 12/217 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	8.8% 9/102 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Musculoskeletal and connective tissue disorders Arthralgia	9.2% 20/217 • Number of events 22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	8.8% 9/102 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Musculoskeletal and connective tissue disorders Back pain	6.0% 13/217 • Number of events 15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	9.8% 10/102 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations COVID-19	11.1% 24/217 • Number of events 24 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	8.8% 9/102 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Infections and infestations Urinary tract infection	5.5% 12/217 • Number of events 17 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	2.0% 2/102 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Metabolism and nutrition disorders Hypokalaemia	6.5% 14/217 • Number of events 16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	2.9% 3/102 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Metabolism and nutrition disorders Hyperglycaemia	2.8% 6/217 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	5.9% 6/102 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.1% 11/217 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	2.0% 2/102 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.1% 9/217 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	6.9% 7/102 • Number of events 13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Injury, poisoning and procedural complications Infusion related reaction	6.9% 15/217 • Number of events 25 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Vascular disorders Hypertension	6.0% 13/217 • Number of events 13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	2.0% 2/102 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Hepatobiliary disorders Hepatic function abnormal	5.1% 11/217 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	0.00% 0/102 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.
Skin and subcutaneous tissue disorders Rash	1.8% 4/217 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.	5.9% 6/102 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion. All cause mortality, SAEs and non-serious adverse events were reported for the safety population that included all randomized participants who received at least 1 dose of any study intervention.

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