Trial Outcomes & Findings for A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM) (NCT NCT03439280)

NCT ID: NCT03439280

Last Updated: 2023-02-24

Results Overview

TEAEs were any untoward medical occurrence (called an adverse event \[AE\]) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)
• Results posted on: 2023-02-24

Participant Flow

Participants took part in the study at 7 investigative sites in the United States from 20 April 2018 to 28 January 2022.

Participants with a diagnosis of relapsed or refractory (R/R) multiple myeloma (MM) were enrolled in Phase 1 to receive mezagitamab in a dose escalating manner and in combination with PomDex. Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.

Participant milestones

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg Mezagitamab 45 mg, subcutaneously (SC), once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.	Phase 2a: Mezagitamab Mezagitamab, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons. TAK-079 dose for this phase was to be determined based on review of the available safety, efficacy, pharmacokinetic, and pharmacodynamic data obtained from the Phase 1 portion of the study. However, Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.
Overall Study STARTED	4	3	12	22	3	6	0
Overall Study COMPLETED	4	3	12	22	3	6	0
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM)

Baseline characteristics by cohort

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=4 Participants Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg n=3 Participants Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg n=12 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg n=22 Participants Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg n=3 Participants Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex n=6 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.	Total n=50 Participants Total of all reporting groups
Age, Continuous	64.3 years STANDARD_DEVIATION 9.71 • n=5 Participants	69.0 years STANDARD_DEVIATION 5.00 • n=7 Participants	67.3 years STANDARD_DEVIATION 5.99 • n=5 Participants	69.3 years STANDARD_DEVIATION 7.59 • n=4 Participants	62.0 years STANDARD_DEVIATION 11.14 • n=21 Participants	64.2 years STANDARD_DEVIATION 8.50 • n=8 Participants	67.3 years STANDARD_DEVIATION 7.59 • n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=8 Participants	17 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants	14 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	33 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	8 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	19 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=8 Participants	41 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	9 Participants n=8 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants	15 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	31 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	7 Participants n=8 Participants
Region of Enrollment United States	4 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants	22 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=8 Participants	50 Participants n=8 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.

TEAEs were any untoward medical occurrence (called an adverse event [AE]) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.

Outcome measures

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=4 Participants Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg n=3 Participants Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg n=12 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg n=22 Participants Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg n=3 Participants Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex n=6 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
Phase 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)	4 Participants	3 Participants	12 Participants	22 Participants	3 Participants	6 Participants

PRIMARY outcome

Timeframe: Cycle 1 (cycle length=28 days)

Population: DLT-evaluable analysis set included participants who received all Cycle 1 doses of mezagitamab and completed Cycle 1 procedures or experienced a DLT in Cycle 1.

DLTs were defined as any of the following events: Grade 4 laboratory abnormalities, except those events that were clearly due to extraneous causes; nonhematologic TEAEs of grade greater than or equal to (>=3) except grade 3 nausea/vomiting, fatigue lasting less than 72 hours, elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that resolves to grade less than or equal to (<=)1 or baseline within 7 days, injection reaction (IR) that responds to symptomatic treatment; Hematologic TEAEs of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade >=4, except grade >=3 hemolysis, grade 3 low platelet or higher count with clinically meaningful bleeding; and an incomplete recovery from treatment-related toxicity causing a greater than (>) 2-week delay in the next scheduled injection before the initiation of Cycle 2 will be considered a DLT.

Outcome measures

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=4 Participants Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg n=3 Participants Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg n=10 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg n=17 Participants Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg n=3 Participants Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex n=4 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.

AE Grades were evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE.

Outcome measures

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=4 Participants Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg n=3 Participants Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg n=12 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg n=22 Participants Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg n=3 Participants Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex n=6 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
Phase 1: Number of Participants With Grade 3 or Higher TEAEs	2 Participants	1 Participants	3 Participants	12 Participants	1 Participants	6 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.

TEAEs were any untoward medical occurrence (called an AE) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.

Outcome measures

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=4 Participants Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg n=3 Participants Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg n=12 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg n=22 Participants Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg n=3 Participants Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex n=6 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
Phase 1: Number of Participants With Serious TEAEs	0 Participants	0 Participants	1 Participants	8 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.

TEAEs leading to discontinuation were any untoward medical occurrence (called an AE) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug leading to discontinuation of any of the study treatment when given in combination.

Outcome measures

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=4 Participants Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg n=3 Participants Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg n=12 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg n=22 Participants Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg n=3 Participants Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex n=6 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
Phase 1: Number of Participants With TEAEs Leading to Treatment Discontinuation	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	3 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)

Population: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.

TEAEs were any untoward medical occurrence (called an AE) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. Dose modification includes dose delayed, reduced, and drug discontinued permanently. Dose reduced includes scenarios where the dose was skipped, held, or missed. Dose modifications also refer to a modification of any drug in the study treatment when given in combination.

Outcome measures

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=4 Participants Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg n=3 Participants Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg n=12 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg n=22 Participants Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg n=3 Participants Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex n=6 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
Phase 1: Number of Participants With TEAEs Leading to Dose Modifications	1 Participants	1 Participants	1 Participants	11 Participants	1 Participants	6 Participants

PRIMARY outcome

Timeframe: Up to approximately 3.7 years

Population: Data was not collected as Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.

ORR is defined as the percentage of participants who achieved a partial response (PR) better during the study. PR is defined as >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 milligram per (mg/) 24 hours. If serum and urine M protein are not measurable, >= 50% decrease in difference between involved and uninvolved free light chain (FLC) levels is required in place of M protein criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose (cycle length=28 days)

Population: Pharmacokinetic (PK) analysis set included those participants from the safety analysis set who had sufficient dosing data and mezagitamab concentration-time data to permit the calculation of PK parameters. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Outcome measures

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=4 Participants Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg n=3 Participants Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg n=12 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg n=22 Participants Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg n=3 Participants Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex n=6 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
Cmax: Maximum Observed Serum Concentration for TAK-079 Cycle 1 Week 1	47.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 1908.7	1660 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 460.1	5810 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 599.9	21300 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 196.6	46000 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 58.0	5690 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 223.5
Cmax: Maximum Observed Serum Concentration for TAK-079 Cycle 2 Week 1	228 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 4373.4	12900 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 142.3	42700 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 86.3	143000 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 66.2	174000 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 76.3	25800 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 69.8

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1 pre-dose and at multiple time points (up to 190.95 hours) post-dose (cycle length=28 days)

Population: PK analysis set included those participants from the safety analysis set who had sufficient dosing data and mezagitamab concentration-time data to permit the calculation of PK parameters. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Outcome measures

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=4 Participants Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg n=3 Participants Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg n=12 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg n=22 Participants Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg n=3 Participants Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex n=6 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
Tmax: Time to Reach the Maximum Observed Serum Concentration (Cmax) for TAK-079 Cycle 1 Week 1	60.18 hours (h) Interval 22.88 to 168.0	70.60 hours (h) Interval 49.35 to 167.88	71.11 hours (h) Interval 44.0 to 168.5	72.55 hours (h) Interval 24.0 to 190.95	73.22 hours (h) Interval 70.23 to 169.3	70.58 hours (h) Interval 46.23 to 173.5
Tmax: Time to Reach the Maximum Observed Serum Concentration (Cmax) for TAK-079 Cycle 2 Week 1	58.77 hours (h) Interval 0.1 to 70.4	71.15 hours (h) Interval 22.78 to 168.57	70.00 hours (h) Interval 0.0 to 167.0	59.12 hours (h) Interval 0.25 to 172.53	71.92 hours (h) Interval 48.88 to 165.12	49.33 hours (h) Interval 5.67 to 70.85

SECONDARY outcome

Timeframe: Cycle 1 and 2: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose (cycle length=28 days)

Population: PK analysis set included those participants from the safety analysis set who had sufficient dosing data and mezagitamab concentration-time data to permit the calculation of PK parameters. Overall number analyzed is the number of participants available for analyses. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Outcome measures

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=4 Participants Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg n=3 Participants Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg n=12 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg n=21 Participants Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg n=3 Participants Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex n=6 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079 Cycle 1 Week 1	32800 hours*nanogram/milliliter (h*ng/mL) Geometric Coefficient of Variation 20.9	160000 hours*nanogram/milliliter (h*ng/mL) Geometric Coefficient of Variation 471.1	547000 hours*nanogram/milliliter (h*ng/mL) Geometric Coefficient of Variation 546.9	2710000 hours*nanogram/milliliter (h*ng/mL) Geometric Coefficient of Variation 83.8	5780000 hours*nanogram/milliliter (h*ng/mL) Geometric Coefficient of Variation 67.7	603000 hours*nanogram/milliliter (h*ng/mL) Geometric Coefficient of Variation 272.9
AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079 Cycle 2 Week 1	10400 hours*nanogram/milliliter (h*ng/mL) Geometric Coefficient of Variation 285970.0	1920000 hours*nanogram/milliliter (h*ng/mL) Geometric Coefficient of Variation 159.8	4780000 hours*nanogram/milliliter (h*ng/mL) Geometric Coefficient of Variation 114.5	19300000 hours*nanogram/milliliter (h*ng/mL) Geometric Coefficient of Variation 79.6	27000000 hours*nanogram/milliliter (h*ng/mL) Geometric Coefficient of Variation 92.1	2690000 hours*nanogram/milliliter (h*ng/mL) Geometric Coefficient of Variation 33.9

SECONDARY outcome

Timeframe: Up to approximately 3.7 years

Population: Response-evaluable analysis set is a subset of the safety analysis set including participants with measurable disease at baseline and at least 1 posttreatment evaluation.

ORR is defined as the percentage of participants who achieved a partial response (PR) or better during the study. PR is defined as >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours. If the serum and urine M-protein were not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels was required in place of the M-protein criteria. If serum and urine M-protein were not measurable, and serum FLC was also not measurable, ≥50% reduction in bone marrow plasma cells was required in place of M-protein, provided the baseline percentage was ≥30%. In addition to the above criteria, if present at baseline, ≥50% reduction in the size of soft tissue plasmacytomas was also required. Two consecutive assessments were needed; no known evidence of progressive or new bone lesions if radiographic studies were performed. Percentages are rounded off to whole number at the nearest decimal.

Outcome measures

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=4 Participants Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg n=3 Participants Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg n=12 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg n=19 Participants Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg n=3 Participants Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex n=6 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
Phase 1: Overall Response Rate (ORR)	25 percentage of participants Interval 0.6 to 80.6	0 percentage of participants Interval 0.0 to 0.0	42 percentage of participants Interval 15.2 to 72.3	47 percentage of participants Interval 24.4 to 71.1	33 percentage of participants Interval 0.8 to 90.6	83 percentage of participants Interval 35.9 to 99.6

SECONDARY outcome

Timeframe: Up to approximately 3.7 years

Population: Response-evaluable analysis set is a subset of the safety analysis set including participants with measurable disease at baseline and at least 1 posttreatment evaluation.

MR is defined as >=25% but <=49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Percentages are rounded off to whole number at the nearest decimal.

Outcome measures

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=4 Participants Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg n=3 Participants Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg n=12 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg n=19 Participants Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg n=3 Participants Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex n=6 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
Percentage of Participants With Minimal Response (MR)	0 percentage of participants	33 percentage of participants	0 percentage of participants	11 percentage of participants	0 percentage of participants	17 percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 3.7 years

Population: The immunogenicity analysis set included those participants from the safety population who had baseline and at least 1 postbaseline sample assessment.

Percentages are rounded off to whole number at the nearest decimal.

Outcome measures

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=2 Participants Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg n=1 Participants Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg n=12 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg n=18 Participants Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg n=3 Participants Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex n=6 Participants Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
Percentage of Participants With Positive Anti-drug Antibodies (ADA)	0 percentage of participants	0 percentage of participants	8 percentage of participants	0 percentage of participants	0 percentage of participants	17 percentage of participants

SECONDARY outcome

Timeframe: From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)

Population: Data was not collected as Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)

Population: Data was not collected as Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)

Population: Data was not collected as Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)

Population: Data was not collected as Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 3.7 years

Population: Data was not collected as Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.

DOR is the time from date of first documentation of response to date of first documented PD. PD is increase of >=25% from lowest response value in any of following:Serum M-protein(increase must be >=0.5 gram per deciliter[g/dL];serum M component increases >=1 g/dL are sufficient to define relapse if starting M component is >=5 g/dL),and/or urine M-protein(increase must be >=200 mg/24 hour), and/or only in participants without measurable serum and urine M-protein levels, difference between involved/uninvolved FLC levels (increase must be >10 mg/dL), and only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell percentage (percentage must be >=10%) or definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or soft tissue plasmacytomas, and development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 3.7 years

Population: Data was not collected as Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.

PFS is time from the date of the first dose until the earliest date of disease progression (PD). PD is increase of >=25% from lowest response value in any of following: Serum M-protein (increase must be >=0.5 g/dL; serum M component increases >=1 g/dL are sufficient to define relapse if starting M component is >=5 g/dL),and/or urine M-protein (increase must be >=200 mg/24 hour), and/or only in participants without measurable serum and urine M-protein levels, difference between involved/uninvolved FLC levels (increase must be >10 mg/dL), and only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell percentage (percentage must be >=10%) or definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or soft tissue plasmacytomas, and development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 3.7 years

Population: Data was not collected as Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.

OS is defined as the time from the date of first dose to the date of death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 3.7 years

Population: Data was not collected as Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.

TTR is defined as the time from the date of the first dose to the date of the first documentation of response (PR [partial response] or better). PR is defined as >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)

Population: DLT-evaluable analysis set included participants who received all Cycle 1 doses of mezagitamab and completed Cycle 1 procedures or experienced a DLT in Cycle 1.

RP2D was determined by dose escalating monotherapy groups.

Outcome measures

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=37 Participants Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
Phase 1: RP2D of TAK-079	600 mg	—	—	—	—	—

Adverse Events

Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 1 deaths

Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg

Serious events: 1 serious events

Other events: 12 other events

Deaths: 7 deaths

Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg

Serious events: 8 serious events

Other events: 21 other events

Deaths: 6 deaths

Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=4 participants at risk Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg n=3 participants at risk Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg n=12 participants at risk Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg n=22 participants at risk Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg n=3 participants at risk Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex n=6 participants at risk Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Cardiac disorders Acute myocardial infarction	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations COVID-19	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Cellulitis	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Diverticulitis	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Influenza	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Renal and urinary disorders Renal failure	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Sepsis	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Soft tissue infection	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Other adverse events

Measure	Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg n=4 participants at risk Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg n=3 participants at risk Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg n=12 participants at risk Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg n=22 participants at risk Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg n=3 participants at risk Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.	Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex n=6 participants at risk Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Psychiatric disorders Agitation	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	13.6% 3/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	25.0% 3/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	18.2% 4/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Cardiac disorders Angina pectoris	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Psychiatric disorders Anxiety	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	75.0% 3/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 2/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 4/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	22.7% 5/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Investigations Blood alkaline phosphatase increased	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Investigations Blood creatinine increased	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Investigations Blood pressure increased	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Bronchitis	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 2/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Psychiatric disorders Bruxism	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations COVID-19 pneumonia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
General disorders Chills	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	13.6% 3/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Investigations Coronavirus test positive	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	25.0% 3/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Cranial nerve paralysis	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 2/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Psychiatric disorders Depression	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	13.6% 3/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Diverticulitis	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Dyskinesia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 2/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
General disorders Early satiety	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 4/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	22.7% 5/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Vascular disorders Flushing	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Folliculitis	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Fungal skin infection	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gingival pain	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Headache	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 4/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Immune system disorders Hypersensitivity	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	18.2% 4/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	13.6% 3/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Influenza	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
General disorders Influenza like illness	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
General disorders Injection site haemorrhage	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Psychiatric disorders Insomnia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	25.0% 3/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	22.7% 5/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Leukopenia	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 2/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	25.0% 3/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	13.6% 3/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Neuropathy peripheral	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Neutropenia	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	50.0% 3/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Investigations Neutrophil count decreased	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	50.0% 3/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Renal and urinary disorders Nocturia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
General disorders Non-cardiac chest pain	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
General disorders Oedema	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
General disorders Oedema peripheral	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	18.2% 4/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Oesophageal candidiasis	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Paraesthesia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Peripheral sensory neuropathy	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
General disorders Peripheral swelling	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Investigations Platelet count decreased	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	13.6% 3/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Renal and urinary disorders Pollakiuria	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash follicular	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Rhinitis	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin laceration	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin mass	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Soft tissue infection	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Tongue ulceration	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Tooth infection	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 2/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	31.8% 7/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Vascular disorders Varicose vein	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Vascular disorders Venous thrombosis limb	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Eye disorders Vision blurred	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 2/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	25.0% 1/4 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	8.3% 1/12 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years) At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: TrialDisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
• Publication restrictions are in place

Restriction type: OTHER