Trial Outcomes & Findings for Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy (NCT NCT05065970)

Last Updated: 2026-04-28

Results Overview

Proteinuria is high levels of protein in the urine and is measured by UPCR. Relative change in UPCR was estimated based on mixed effects model for repeated measure (MMRM) model. Least squares (LS) mean and standard error (SE) were reported. The reference proteinuria value before start of treatment is defined as the mean of the values determined at screening and prior to baseline (visit 2) predose (UPCR from 24h urine). Negative change from baseline indicates less proteinuria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

Baseline, Month 9

Results posted on

2026-04-28

Participant Flow

Participants were enrolled at investigative sites in Belgium, Bulgaria, Czechia, Georgia, Germany, Japan, Republic of Korea, Malaysia, Philippines, Serbia, Spain, Taiwan, Ukraine, and the United States from 31 August 2021 to 06 May 2024.

A total of 54 participants diagnosed with Immunoglobulin A Nephropathy (IgAN) were enrolled in the study, of which 48 participants completed the study. The study had 2 parts - Part 1 (Global Cohort) and Part 2 (Japanese Cohort).

Participant milestones

Participant milestones
Measure	Part 1: Placebo Participants were administered felzartamab matching placebo as an intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M1 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.
Overall Study STARTED	12	12	11	13	6
Overall Study COMPLETED	10	11	9	12	6
Overall Study NOT COMPLETED	2	1	2	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Placebo Participants were administered felzartamab matching placebo as an intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M1 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.
Overall Study Investigator Decision	1	0	0	0
Overall Study Requires Prohibited Medication	0	0	1	1
Overall Study Withdrawal of Consent	1	1	1	0

Baseline Characteristics

Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Felzartamab Dosing Arm M1 n=12 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 n=11 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 n=13 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort n=6 Participants Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Total n=54 Participants Total of all reporting groups	Part 1: Placebo n=12 Participants Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
Age, Continuous	47.4 years STANDARD_DEVIATION 10.41 • n=24 Participants	35.1 years STANDARD_DEVIATION 14.31 • n=23 Participants	39.2 years STANDARD_DEVIATION 7.20 • n=73 Participants	51.7 years STANDARD_DEVIATION 14.19 • n=12 Participants	41.6 years STANDARD_DEVIATION 12.30 • n=60 Participants	39.6 years STANDARD_DEVIATION 11.84 • n=9 Participants
Sex: Female, Male Female	6 Participants n=24 Participants	3 Participants n=23 Participants	3 Participants n=73 Participants	3 Participants n=12 Participants	18 Participants n=60 Participants	3 Participants n=9 Participants
Sex: Female, Male Male	6 Participants n=24 Participants	8 Participants n=23 Participants	10 Participants n=73 Participants	3 Participants n=12 Participants	36 Participants n=60 Participants	9 Participants n=9 Participants
Race/Ethnicity, Customized Race · White	6 Participants n=24 Participants	9 Participants n=23 Participants	9 Participants n=73 Participants	0 Participants n=12 Participants	33 Participants n=60 Participants	9 Participants n=9 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	1 Participants n=24 Participants	0 Participants n=23 Participants	0 Participants n=73 Participants	0 Participants n=12 Participants	1 Participants n=60 Participants	0 Participants n=9 Participants
Race/Ethnicity, Customized Race · Asian	5 Participants n=24 Participants	2 Participants n=23 Participants	4 Participants n=73 Participants	6 Participants n=12 Participants	20 Participants n=60 Participants	3 Participants n=9 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	1 Participants n=24 Participants	0 Participants n=23 Participants	2 Participants n=73 Participants	0 Participants n=12 Participants	4 Participants n=60 Participants	1 Participants n=9 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	8 Participants n=24 Participants	8 Participants n=23 Participants	8 Participants n=73 Participants	6 Participants n=12 Participants	41 Participants n=60 Participants	11 Participants n=9 Participants
Race/Ethnicity, Customized Ethnicity · Not Reported	2 Participants n=24 Participants	3 Participants n=23 Participants	3 Participants n=73 Participants	0 Participants n=12 Participants	8 Participants n=60 Participants	0 Participants n=9 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	1 Participants n=24 Participants	0 Participants n=23 Participants	0 Participants n=73 Participants	0 Participants n=12 Participants	1 Participants n=60 Participants	0 Participants n=9 Participants
Urine Protein to Creatinine Ratio (UPCR)	1.57 gram per gram (g/g) STANDARD_DEVIATION 0.742 • n=24 Participants	1.76 gram per gram (g/g) STANDARD_DEVIATION 0.828 • n=23 Participants	1.69 gram per gram (g/g) STANDARD_DEVIATION 1.301 • n=73 Participants	1.02 gram per gram (g/g) STANDARD_DEVIATION 0.324 • n=12 Participants	1.68 gram per gram (g/g) STANDARD_DEVIATION 0.999 • n=60 Participants	2.04 gram per gram (g/g) STANDARD_DEVIATION 1.158 • n=9 Participants

PRIMARY outcome

Timeframe: Baseline, Month 9

Population: The full analysis set (FAS) included all participants randomized to Part 1 of the study. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. The change from baseline in UPCR was planned to be analyzed in Part 1 only.

Outcome measures

Outcome measures
Measure	Part 1: Felzartamab Dosing Arm M1 n=11 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 n=9 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 n=12 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 1: Placebo n=11 Participants Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
Part 1: Relative Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) in 24-hour Urine at Month 9	-16.5 gram per gram (g/g) Standard Error 19.41	-30.6 gram per gram (g/g) Standard Error 21.72	-38.5 gram per gram (g/g) Standard Error 16.60	—	-24.7 gram per gram (g/g) Standard Error 19.43

SECONDARY outcome

Timeframe: Up to 9 months

Population: This outcome measure was planned to be analyzed for the overall participants irrespective of the group they were randomized to. Only those participants who had evaluable IgA data and felzartamab serum concentrations are reported as the overall number of participants analyzed. Number analyzed signifies the number of participants available for analysis for the specified category.

All felzartamab and placebo-treated participants with evaluable IgA data and felzartamab serum concentrations (in felzartamab-treated participants only) were divided into exposure quartiles using the sum of measurable felzartamab Ctrough values up to 9 months after the first dose. Percent change from baseline in IgA concentration in these participants was summarized as per each serum concentration quartile.

Outcome measures

Outcome measures
Measure	Part 1: Felzartamab Dosing Arm M1 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 1: Placebo n=45 Participants Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
Integrative Analysis of Several Endpoints: Percent Change From Baseline in Immunoglobulin A (IgA) Concentration by Predose Serum Concentration (Ctrough) Group Serum Concentration 0-180 µg/mL	—	—	—	—	-6.12 percent change Standard Deviation 15.0
Integrative Analysis of Several Endpoints: Percent Change From Baseline in Immunoglobulin A (IgA) Concentration by Predose Serum Concentration (Ctrough) Group Serum Concentration 180-370 µg/mL	—	—	—	—	-14.1 percent change Standard Deviation 15.6
Integrative Analysis of Several Endpoints: Percent Change From Baseline in Immunoglobulin A (IgA) Concentration by Predose Serum Concentration (Ctrough) Group Serum Concentration 370-850 µg/mL	—	—	—	—	-19.7 percent change Standard Deviation 22.7
Integrative Analysis of Several Endpoints: Percent Change From Baseline in Immunoglobulin A (IgA) Concentration by Predose Serum Concentration (Ctrough) Group Serum Concentration >850 µg/mL	—	—	—	—	-26.1 percent change Standard Deviation 10.1

SECONDARY outcome

Timeframe: Up to 1 week

Population: This outcome measure was planned to be analyzed for all the felzartamab-treated participants together, irrespective of the dose group they were randomized to. Overall number of participants analyzed signifies the number of participants with evaluable data up to week 1. Number analyzed signifies the number of participants available for analysis for the specified category.

All participants with evaluable maximum felzartamab concentrations after the first dose were included in the analysis. Cmax values were assessed by infusion-related reaction status after the first dose.

Outcome measures

Outcome measures
Measure	Part 1: Felzartamab Dosing Arm M1 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 1: Placebo n=39 Participants Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
Integrative Analysis of Several Endpoints: Maximum Serum Concentrations (Cmax) as Per the Infusion-Related Reactions (IRRs) After the First Dose Cmax in Participants With IRR	—	—	—	—	445 µg/mL Standard Deviation 198
Integrative Analysis of Several Endpoints: Maximum Serum Concentrations (Cmax) as Per the Infusion-Related Reactions (IRRs) After the First Dose Cmax in Participants Without IRR	—	—	—	—	367 µg/mL Standard Deviation 131

SECONDARY outcome

Timeframe: Baseline, Months 3,6,12,18 and 24

Population: The FAS included all participants randomized to Part 1 of the study. 'Number analyzed (n)' signifies number of participants evaluable for this outcome measure. The change from baseline in UPCR was planned to be analyzed in Part 1 only.

Proteinuria is high levels of protein in the urine and is measured by UPCR. Relative change in UPCR will be estimated based on an MMRM model. The reference proteinuria value before start of treatment is defined as the mean of the values determined at screening and prior to baseline (visit 2) predose (UPCR from 24h urine). Negative change from baseline indicates less proteinuria.

Outcome measures

Outcome measures
Measure	Part 1: Felzartamab Dosing Arm M1 n=12 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 n=11 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 n=13 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 1: Placebo n=12 Participants Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
Part 1: Relative Change From Baseline in UPCR in 24-hour Urine at Months 3, 6, 12, 18 and 24 Change at Month 12	1.1 g/g Standard Error 19.49	-44.4 g/g Standard Error 21.81	-38.2 g/g Standard Error 19.02	—	-3.9 g/g Standard Error 19.52
Part 1: Relative Change From Baseline in UPCR in 24-hour Urine at Months 3, 6, 12, 18 and 24 Change at Month 18	-24.9 g/g Standard Error 23.30	-39.3 g/g Standard Error 25.54	-48.3 g/g Standard Error 21.81	—	-11.0 g/g Standard Error 23.40
Part 1: Relative Change From Baseline in UPCR in 24-hour Urine at Months 3, 6, 12, 18 and 24 Change at Month 24	-15.3 g/g Standard Error 34.24	-30.9 g/g Standard Error 38.03	-48.6 g/g Standard Error 32.19	—	-38.1 g/g Standard Error 33.67
Part 1: Relative Change From Baseline in UPCR in 24-hour Urine at Months 3, 6, 12, 18 and 24 Change at Month 6	-29.3 g/g Standard Error 20.07	-44.5 g/g Standard Error 23.32	-43.9 g/g Standard Error 21.29	—	-12.8 g/g Standard Error 20.85
Part 1: Relative Change From Baseline in UPCR in 24-hour Urine at Months 3, 6, 12, 18 and 24 Change at Month 3	-7.5 g/g Standard Error 13.47	-35.1 g/g Standard Error 17.06	-35.5 g/g Standard Error 14.57	—	-18.0 g/g Standard Error 13.09

SECONDARY outcome

Timeframe: Months 3,6,9,12,18 and 24

Population: The FAS included all participants randomized to Part 1 of the study. 'Number analyzed (n)' signifies number of participants evaluable for this outcome measure. The number of participants with complete response were planned to be analyzed in Part 1 only.

CR was defined as the reduction of proteinuria to less than 0.3 g/g UPCR, serum albumin within the reference range of the central laboratory and stable estimated glomerular filtration rate (eGFR) (at least 80% of value at baseline visit).

Outcome measures

Outcome measures
Measure	Part 1: Felzartamab Dosing Arm M1 n=12 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 n=11 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 n=13 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 1: Placebo n=12 Participants Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
Part 1: Number of Participants With Complete Response (CR) at Months 3, 6, 9, 12, 18 and 24 Month 3	0 Participants	0 Participants	1 Participants	—	0 Participants
Part 1: Number of Participants With Complete Response (CR) at Months 3, 6, 9, 12, 18 and 24 Month 6	1 Participants	0 Participants	1 Participants	—	0 Participants
Part 1: Number of Participants With Complete Response (CR) at Months 3, 6, 9, 12, 18 and 24 Month 9	0 Participants	0 Participants	4 Participants	—	0 Participants
Part 1: Number of Participants With Complete Response (CR) at Months 3, 6, 9, 12, 18 and 24 Month 12	0 Participants	0 Participants	3 Participants	—	0 Participants
Part 1: Number of Participants With Complete Response (CR) at Months 3, 6, 9, 12, 18 and 24 Month 18	0 Participants	0 Participants	4 Participants	—	0 Participants
Part 1: Number of Participants With Complete Response (CR) at Months 3, 6, 9, 12, 18 and 24 Month 24	0 Participants	0 Participants	4 Participants	—	1 Participants

SECONDARY outcome

Timeframe: Months 3,6,9,12,18 and 24

Population: The FAS included all participants randomized to Part 1 of the study. 'Number analyzed (n)' signifies number of participants evaluable for this outcome measure. The percentage of participants with response were planned to be analyzed in Part 1 only.

Response was defined as reduction of proteinuria to below 0.6 g/g (UPCR) and stable eGFR (at least 80% of value at baseline visit), but not CR.

Outcome measures

Outcome measures
Measure	Part 1: Felzartamab Dosing Arm M1 n=12 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 n=11 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 n=13 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 1: Placebo n=12 Participants Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
Part 1: Percentage of Participants With Response at Months 3, 6, 9, 12, 18 and 24 Month 3	9.1 percentage of participants	0 percentage of participants	44.4 percentage of participants	—	8.3 percentage of participants
Part 1: Percentage of Participants With Response at Months 3, 6, 9, 12, 18 and 24 Month 6	9.1 percentage of participants	0 percentage of participants	55.6 percentage of participants	—	0 percentage of participants
Part 1: Percentage of Participants With Response at Months 3, 6, 9, 12, 18 and 24 Month 9	0 percentage of participants	11.1 percentage of participants	8.3 percentage of participants	—	9.1 percentage of participants
Part 1: Percentage of Participants With Response at Months 3, 6, 9, 12, 18 and 24 Month 12	0 percentage of participants	22.2 percentage of participants	27.3 percentage of participants	—	9.1 percentage of participants
Part 1: Percentage of Participants With Response at Months 3, 6, 9, 12, 18 and 24 Month 18	0 percentage of participants	22.2 percentage of participants	16.7 percentage of participants	—	0 percentage of participants
Part 1: Percentage of Participants With Response at Months 3, 6, 9, 12, 18 and 24 Month 24	11.1 percentage of participants	12.5 percentage of participants	20.0 percentage of participants	—	0 percentage of participants

SECONDARY outcome

Timeframe: Months 6, 9,12,18 and 24

Outcome measures

Outcome measures
Measure	Part 1: Felzartamab Dosing Arm M1 n=12 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 n=11 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 n=13 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 1: Placebo n=12 Participants Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
Part 1: Albumin-Creatinine Ratio (ACR) at Months 6, 9, 12, 18 and 24 Month 18	0.729 milligrams per gram (mg/g) Standard Deviation 0.3501	0.822 milligrams per gram (mg/g) Standard Deviation 0.6715	0.827 milligrams per gram (mg/g) Standard Deviation 0.9789	—	1.305 milligrams per gram (mg/g) Standard Deviation 0.9155
Part 1: Albumin-Creatinine Ratio (ACR) at Months 6, 9, 12, 18 and 24 Month 6	0.802 milligrams per gram (mg/g) Standard Deviation 0.4633	0.841 milligrams per gram (mg/g) Standard Deviation 0.7925	0.723 milligrams per gram (mg/g) Standard Deviation 1.0052	—	1.278 milligrams per gram (mg/g) Standard Deviation 0.8101
Part 1: Albumin-Creatinine Ratio (ACR) at Months 6, 9, 12, 18 and 24 Month 9	0.830 milligrams per gram (mg/g) Standard Deviation 0.3378	0.834 milligrams per gram (mg/g) Standard Deviation 0.4391	0.948 milligrams per gram (mg/g) Standard Deviation 1.1494	—	1.053 milligrams per gram (mg/g) Standard Deviation 0.7517
Part 1: Albumin-Creatinine Ratio (ACR) at Months 6, 9, 12, 18 and 24 Month 12	1.062 milligrams per gram (mg/g) Standard Deviation 0.5072	0.702 milligrams per gram (mg/g) Standard Deviation 0.4307	1.013 milligrams per gram (mg/g) Standard Deviation 1.5322	—	1.324 milligrams per gram (mg/g) Standard Deviation 0.7726
Part 1: Albumin-Creatinine Ratio (ACR) at Months 6, 9, 12, 18 and 24 Month 24	0.903 milligrams per gram (mg/g) Standard Deviation 0.5079	0.913 milligrams per gram (mg/g) Standard Deviation 0.6047	0.622 milligrams per gram (mg/g) Standard Deviation 0.9405	—	1.102 milligrams per gram (mg/g) Standard Deviation 0.8979

SECONDARY outcome

Timeframe: Up to 2 years

Population: The FAS included all participants randomized to Part 1 of the study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. The duration of response was planned to be analyzed in Part 1 only.

Duration of response was defined as date of 1st observation of progressive disease minus date of 1st observation of response+1 day. Duration of response was estimated by Kaplan Meier method.

Outcome measures

Outcome measures
Measure	Part 1: Felzartamab Dosing Arm M1 n=2 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 n=2 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 n=8 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 1: Placebo n=3 Participants Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
Part 1: Duration of Response	140 days Interval 92.0 to The upper limit of 95% confidence interval was not estimable due to insufficient number of participants with events.	451 days The upper and lower limits of 95% confidence interval were not estimable due to insufficient number of participants with events.	188 days Interval 83.0 to The upper limit of 95% confidence interval was not estimable due to insufficient number of participants with events.	—	250 days Interval 78.0 to The upper limit of 95% confidence interval was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to 2 years

Population: The FAS included all participants randomized to Part 1 of the study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. The time to response was planned to be analyzed in Part 1 only.

Time to response was defined as date of 1st observation of response minus date of randomization+1 day. Time to response was estimated by Kaplan Meier method.

Outcome measures

Outcome measures
Measure	Part 1: Felzartamab Dosing Arm M1 n=2 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 n=2 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 n=8 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 1: Placebo n=3 Participants Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
Part 1: Time to Response	NA days The median, upper and lower limits of 95% confidence interval were not estimable due to insufficient number of participants with events.	NA days The median, upper and lower limits of 95% confidence interval were not estimable due to insufficient number of participants with events.	176 days Interval 85.0 to The upper limit of 95% confidence interval was not estimable due to insufficient number of participants with events.	—	767 days Interval 300.0 to The upper limit of 95% confidence interval was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Baseline, Months 3,6,9,12,15,18, and 24

Population: All enrolled participants included all randomized participants from the FAS plus all Japanese participants who were enrolled in Part 2. 'Number analyzed (n)' signifies number of participants evaluable for this outcome measure.

eGFR was calculated as per the chronic kidney disease epidemiology collaboration (CKD-EPI) equation. eGFR =141×min(Scr/κ, 1)α×max(Scr κ,1)-1.209×0.993Age ×1.018\[if female\]×1.159 \[if black\] where: * Scr is serum creatinine in μmol/L, * κ is 61.9 for females and 79.6 for males, * α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1 eGFR as a measure of kidney function. eGFR was calculated in terms of milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2). A numerically smaller negative change in eGFR indicates a slowing in kidney disease progression.

Outcome measures

Outcome measures
Measure	Part 1: Felzartamab Dosing Arm M1 n=12 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 n=11 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 n=13 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort n=6 Participants Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 1: Placebo n=12 Participants Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
Change From Baseline in eGFR Over Time Change at Month 24	-7.394 mL/min/1.73 m^2 Standard Deviation 6.0913	-3.342 mL/min/1.73 m^2 Standard Deviation 17.0161	-6.210 mL/min/1.73 m^2 Standard Deviation 9.9485	—	-9.550 mL/min/1.73 m^2 Standard Deviation 18.1470
Change From Baseline in eGFR Over Time Change at Month 12	-4.618 mL/min/1.73 m^2 Standard Deviation 7.9684	-0.747 mL/min/1.73 m^2 Standard Deviation 15.3308	-4.198 mL/min/1.73 m^2 Standard Deviation 9.1530	-8.959 mL/min/1.73 m^2 Standard Deviation 5.6681	-8.299 mL/min/1.73 m^2 Standard Deviation 11.1636
Change From Baseline in eGFR Over Time Change at Month 18	-6.707 mL/min/1.73 m^2 Standard Deviation 8.4971	2.167 mL/min/1.73 m^2 Standard Deviation 11.0455	-4.778 mL/min/1.73 m^2 Standard Deviation 11.7583	—	-11.131 mL/min/1.73 m^2 Standard Deviation 9.7842
Change From Baseline in eGFR Over Time Change at Month 3	2.058 mL/min/1.73 m^2 Standard Deviation 4.9858	8.100 mL/min/1.73 m^2 Standard Deviation 18.1222	4.224 mL/min/1.73 m^2 Standard Deviation 8.3131	1.011 mL/min/1.73 m^2 Standard Deviation 6.3803	-1.985 mL/min/1.73 m^2 Standard Deviation 7.5920
Change From Baseline in eGFR Over Time Change at Month 6	-2.560 mL/min/1.73 m^2 Standard Deviation 6.6112	3.914 mL/min/1.73 m^2 Standard Deviation 12.4652	0.033 mL/min/1.73 m^2 Standard Deviation 12.7546	0.296 mL/min/1.73 m^2 Standard Deviation 7.1089	-8.163 mL/min/1.73 m^2 Standard Deviation 12.4166
Change From Baseline in eGFR Over Time Change at Month 9	-5.792 mL/min/1.73 m^2 Standard Deviation 7.3286	3.619 mL/min/1.73 m^2 Standard Deviation 11.2770	-4.199 mL/min/1.73 m^2 Standard Deviation 15.8864	-1.890 mL/min/1.73 m^2 Standard Deviation 2.9519	-10.006 mL/min/1.73 m^2 Standard Deviation 9.3866

SECONDARY outcome

Timeframe: From the first dose until 28 days after last dose of study drug (up to 191 days)

Population: Safety analysis set included all participants who received at least one dose of trial treatment.

TEAEs were defined as any AEs reported after the start of trial treatment until 28 days after the last trial treatment, defined as the treatment-emergent period. TESAEs were TEAEs that met the following criteria: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition.

Outcome measures

Outcome measures
Measure	Part 1: Felzartamab Dosing Arm M1 n=12 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 n=11 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 n=13 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort n=6 Participants Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 1: Placebo n=12 Participants Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) TEAE	10 Participants	9 Participants	11 Participants	3 Participants	6 Participants
Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) TESAE	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Predose and 30 minutes post-dose on Days 1, 15, 29; predose on Days 8, 57, 85, 113, 141; Post Treatment Days 169 and 267

Population: PK analysis set included all participants with any available quantifiable felzartamab serum concentration data. 'Number analyzed (n)' signifies number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1: Felzartamab Dosing Arm M1 n=11 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 n=13 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 n=6 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 1: Placebo n=12 Participants Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
Serum Concentrations of Felzartamab Over Time Day 29: 30 mins postdose	471802.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 29.7	868596.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 30.2	696420.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 22.7	—	94110.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 42.2
Serum Concentrations of Felzartamab Over Time Day 57: Predose	70569.7 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 68.4	126530.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 40.1	132181.4 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 69.6	—	5243.4 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 1663.5
Serum Concentrations of Felzartamab Over Time Day 85: Predose	21010.4 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 3668.4	55920.7 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 89.4	69524.7 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 96.5	—	69.6 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 153.0
Serum Concentrations of Felzartamab Over Time Day 113: Predose	849.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 2399.8	28697.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 209.5	63543.2 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 95.0	—	74.6 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 199.2
Serum Concentrations of Felzartamab Over Time Day 141: Predose	50.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 0.0	59744.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 50.9	18172.1 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 9900.0	—	74.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 194.4
Serum Concentrations of Felzartamab Over Time Post Treatment Day 169	50.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 0.0	48355.6 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 109.3	35243.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 194.3	—	64.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 104.8
Serum Concentrations of Felzartamab Over Time Post Treatment Day 267	50.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 0.0	50.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 0.0	50.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 0.0	—	72.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 176.5
Serum Concentrations of Felzartamab Over Time Day 1: Predose	54.6 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 28.2	50.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 0.0	50.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 0.0	—	67.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 143.5
Serum Concentrations of Felzartamab Over Time Day 1: 30 mins postdose	320616.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 56.2	424347.7 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 42.9	355517.2 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 21.9	—	204326.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 3176.6
Serum Concentrations of Felzartamab Over Time Day 8: Predose	111734.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 17.7	119475.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 29.9	119280.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 35.6	—	123890.6 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 34.3
Serum Concentrations of Felzartamab Over Time Day 15: Predose	73299.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 136.9	242622.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 14.9	217362.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 21.7	—	58680.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 39.6
Serum Concentrations of Felzartamab Over Time Day 15: 30 mins postdose	564030.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 14.5	726082.1 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 18.0	579946.2 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 19.9	—	479855.1 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 27.8
Serum Concentrations of Felzartamab Over Time Day 29: Predose	142190.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 28.3	156053.1 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 777.0	339770.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 39.1	—	93782.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 40.0

SECONDARY outcome

Timeframe: From the first dose up to the end of the study (up to 2 years)

Population: The Immunogenicity analysis set included all participants with at least one ADA sample. 'Number analyzed (n)' signifies number of participants evaluable for this outcome measure.

Blood samples were collected for measurement of anti-felzartamab antibodies in the serum. Number of participants with Anti-drug antibody (ADA) status positive/negative was summarized.

Outcome measures

Outcome measures
Measure	Part 1: Felzartamab Dosing Arm M1 n=12 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 n=11 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 n=13 Participants Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort n=6 Participants Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 1: Placebo n=12 Participants Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
Percentage of Participants With Anti- Felzartamab Antibodies Positive (Post-baseline Visits)	6 Participants	3 Participants	3 Participants	1 Participants	1 Participants
Percentage of Participants With Anti- Felzartamab Antibodies Negative (Post-baseline Visits)	6 Participants	7 Participants	10 Participants	5 Participants	11 Participants

Adverse Events

Part 1: Placebo

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Part 1: Felzartamab Dosing Arm M1

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Part 1: Felzartamab Dosing Arm M2

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Part 1: Felzartamab Dosing Arm M3

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Part 2: Japan Cohort

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Placebo n=12 participants at risk Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M1 n=12 participants at risk Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 n=11 participants at risk Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 n=13 participants at risk Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort n=6 participants at risk Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dedifferentiated liposarcoma	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.

Other adverse events

Other adverse events
Measure	Part 1: Placebo n=12 participants at risk Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M1 n=12 participants at risk Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M2 n=11 participants at risk Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Part 1: Felzartamab Dosing Arm M3 n=13 participants at risk Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Part 2: Japan Cohort n=6 participants at risk Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.
Gastrointestinal disorders Nausea	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
General disorders Chest pain	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Nervous system disorders Dizziness	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	18.2% 2/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Investigations Amylase increased	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Investigations Lipase abnormal	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Investigations Lipase increased	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Psychiatric disorders Anxiety	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Psychiatric disorders Insomnia	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 1/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Psychiatric disorders Depression	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 1/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Bacterial infection	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations COVID-19	25.0% 3/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	33.3% 4/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	18.2% 2/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	46.2% 6/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	33.3% 2/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Nasopharyngitis	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	27.3% 3/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	15.4% 2/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 1/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 2/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	18.2% 2/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Bronchitis	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Cellulitis	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 1/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Diarrhoea infectious	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Oral herpes	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Pharyngitis	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 1/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Urethritis	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Urinary tract infection	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Viral infection	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	15.4% 2/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Gastrointestinal disorders Dyspepsia	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Gastrointestinal disorders Toothache	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	18.2% 2/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 1/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Gastrointestinal disorders Haemorrhoids	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Gastrointestinal disorders Vomiting	16.7% 2/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
General disorders Fatigue	16.7% 2/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
General disorders Oedema peripheral	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
General disorders Pyrexia	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 2/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
General disorders Influenza like illness	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
General disorders Malaise	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
General disorders Pain	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
General disorders Vessel puncture site haematoma	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	18.2% 2/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	15.4% 2/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 1/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Injury, poisoning and procedural complications Eye injury	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Injury, poisoning and procedural complications Hand fracture	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Injury, poisoning and procedural complications Joint injury	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Nervous system disorders Headache	16.7% 2/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Nervous system disorders Somnolence	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Nervous system disorders Syncope	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	15.4% 2/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Back pain	16.7% 2/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 1/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Investigations Alanine aminotransferase increased	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Investigations Blood bicarbonate decreased	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Investigations Digestive enzyme abnormal	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Investigations Electrocardiogram T wave abnormal	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Investigations Gamma-glutamyltransferase increased	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Investigations Liver function test increased	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Renal and urinary disorders Haematuria	16.7% 2/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	15.4% 2/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Renal and urinary disorders Chromaturia	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Renal and urinary disorders Nocturia	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 2/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 2/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 1/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Blood and lymphatic system disorders Anaemia	16.7% 2/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Blood and lymphatic system disorders Leukopenia	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Cardiac disorders Sinus arrhythmia	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Blood and lymphatic system disorders Lymphopenia	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Eye disorders Vision blurred	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Eye disorders Swelling of eyelid	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Cardiac disorders Coronary artery stenosis	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Immune system disorders Cytokine release syndrome	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Immune system disorders Drug hypersensitivity	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Metabolism and nutrition disorders Hyperglycaemia	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Skin and subcutaneous tissue disorders Neurodermatitis	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Vascular disorders Hypertension	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Vascular disorders Hypotension	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 1/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Ear and labyrinth disorders Ear pain	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Reproductive system and breast disorders Penile pain	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Hordeolum	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 1/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Laryngitis	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	15.4% 2/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Candida infection	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Conjunctivitis bacterial	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Gastrointestinal bacterial infection	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Influenza	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Keratitis bacterial	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 1/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Otitis externa	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Paronychia	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Respiratory tract infection	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Sinusitis	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Infections and infestations Subcutaneous abscess	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Gastrointestinal disorders Gastritis	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 1/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	15.4% 2/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Bronchial disorder	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
General disorders Non-cardiac chest pain	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Injury, poisoning and procedural complications Muscle contusion	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 1/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Injury, poisoning and procedural complications Skin laceration	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Articular calcification	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Joint stiffness	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Nervous system disorders Migraine	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Renal and urinary disorders Azotaemia	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Renal and urinary disorders Glycosuria	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Renal and urinary disorders Renal impairment	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Renal and urinary disorders Urine flow decreased	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Investigations Blood bilirubin increased	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Investigations Blood creatine phosphokinase increased	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Investigations SARS-CoV-2 test positive	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Blood and lymphatic system disorders Polycythaemia	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Psychiatric disorders Adjustment disorder with anxiety	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Immune system disorders Device allergy	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Immune system disorders Hypogammaglobulinaemia	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Cardiac disorders Angina pectoris	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Cardiac disorders Coronary artery occlusion	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Cardiac disorders Palpitations	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	7.7% 1/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Eye disorders Presbyopia	8.3% 1/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Ear and labyrinth disorders Motion sickness	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	9.1% 1/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/12 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/11 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	0.00% 0/13 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.	16.7% 1/6 • From signing of informed consent up to the end of the study (up to 24 months) Safety analysis set included all participants who received at least one dose of trial treatment.

Additional Information

US Biogen Clinical Trial Center

Biogen

Phone: 866-633-4636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Publication restrictions are in place

Restriction type: OTHER