Trial Outcomes & Findings for A Phase 2 Study of RO7490677 In Participants With Myelofibrosis (NCT NCT01981850)

NCT ID: NCT01981850

Last Updated: 2022-01-05

Results Overview

ORR was defined as the percent of participants with a response according to the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria. This was defined as those participants who achieved clinical improvement (CI), partial remission (PR), or complete remission (CR) at a post-baseline assessment of treatment response OR had at least stable disease (SD) for three consecutive end-of-cycle response assessments (e.g. Day 1 of the subsequent cycle) in conjunction with improvement in the bone marrow fibrosis score relative to baseline by at least one grade at any time point during the period of stable disease.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 125 participants
• Primary outcome timeframe: Up until and including completion of 6 cycles. Each cycle is 28 days.
• Results posted on: 2022-01-05

Participant Flow

A total of 125 participants were enrolled at sites in 8 different countries.

One randomized participant in Stage 2 did not receive the study treatment, bringing the total number of treated participants to 124.

Participant milestones

Measure	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W Participants who completed the main phase of treatment moved to the open label extension. They were treated with single agent PRM-151 at a dose of 10 mg/kg administered as an IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W + Ruxolitinib Participants who completed the main phase of treatment moved to the open label extension. They were treated with PRM-151 at a dose of 10 mg/kg administered as an IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.
Main Phase Stage 1 STARTED	8	7	6	6	0	0	0	0	0	0
Main Phase Stage 1 COMPLETED	5	5	4	6	0	0	0	0	0	0
Main Phase Stage 1 NOT COMPLETED	3	2	2	0	0	0	0	0	0	0
Main Phase Stage 2 STARTED	0	0	0	0	33	32	32	0	0	0
Main Phase Stage 2 COMPLETED	0	0	0	0	20	16	15	0	0	0
Main Phase Stage 2 NOT COMPLETED	0	0	0	0	13	16	17	0	0	0
Open Label Extension (OLE) STARTED	0	0	0	0	0	0	0	13	5	48
Open Label Extension (OLE) COMPLETED	0	0	0	0	0	0	0	1	0	0
Open Label Extension (OLE) NOT COMPLETED	0	0	0	0	0	0	0	12	5	48

Reasons for withdrawal

Measure	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W Participants who completed the main phase of treatment moved to the open label extension. They were treated with single agent PRM-151 at a dose of 10 mg/kg administered as an IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W + Ruxolitinib Participants who completed the main phase of treatment moved to the open label extension. They were treated with PRM-151 at a dose of 10 mg/kg administered as an IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.
Main Phase Stage 1 Death	2	0	0	0	0	0	0	0	0	0
Main Phase Stage 1 Informed Consent Withdrawn	1	0	0	0	0	0	0	0	0	0
Main Phase Stage 1 Lack of Efficacy	0	2	0	0	0	0	0	0	0	0
Main Phase Stage 1 Various reasons	0	0	2	0	0	0	0	0	0	0
Main Phase Stage 2 Adverse Event	0	0	0	0	6	5	7	0	0	0
Main Phase Stage 2 Informed Consent Withdrawn	0	0	0	0	4	3	3	0	0	0
Main Phase Stage 2 Lack of Efficacy	0	0	0	0	1	2	0	0	0	0
Main Phase Stage 2 Various reasons	0	0	0	0	2	0	1	0	0	0
Main Phase Stage 2 Progressive Disease	0	0	0	0	0	6	6	0	0	0
Open Label Extension (OLE) Adverse Event	0	0	0	0	0	0	0	2	1	8
Open Label Extension (OLE) Lack of Efficacy	0	0	0	0	0	0	0	4	1	19
Open Label Extension (OLE) Various reasons	0	0	0	0	0	0	0	3	1	3
Open Label Extension (OLE) Progressive Disease	0	0	0	0	0	0	0	3	2	9
Open Label Extension (OLE) Informed Consent Withdrawn	0	0	0	0	0	0	0	0	0	8
Open Label Extension (OLE) Lost to Follow-up	0	0	0	0	0	0	0	0	0	1

Baseline Characteristics

Main Phase Stage 1 reported separately from Main Phase Stage 2.

Baseline characteristics by cohort

Measure	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W n=33 Participants Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W n=32 Participants Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W n=32 Participants Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Total n=124 Participants Total of all reporting groups
Age, Continuous	64.3 Years STANDARD_DEVIATION 11.4 • n=8 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	70.7 Years STANDARD_DEVIATION 6.3 • n=7 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	66.0 Years STANDARD_DEVIATION 7.3 • n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	66.2 Years STANDARD_DEVIATION 8.6 • n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	70.6 Years STANDARD_DEVIATION 7.1 • n=33 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	70.2 Years STANDARD_DEVIATION 6.5 • n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	69.4 Years STANDARD_DEVIATION 8.9 • n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	70.1 Years STANDARD_DEVIATION 7.5 • n=97 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.
Sex: Female, Male Female	5 Participants n=8 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	2 Participants n=7 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	3 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	5 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	16 Participants n=33 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	8 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	11 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	35 Participants n=97 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.
Sex: Female, Male Male	3 Participants n=8 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	5 Participants n=7 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	3 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	1 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	17 Participants n=33 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	24 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	21 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	62 Participants n=97 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=8 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=7 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	1 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	—	—	—	1 Participants n=27 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=8 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	7 Participants n=7 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	4 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	6 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	—	—	—	25 Participants n=27 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=7 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	1 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	—	—	—	1 Participants n=27 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=7 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	1 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=33 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	0 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	0 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	0 Participants n=97 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.
Race (NIH/OMB) Asian	0 Participants n=8 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=7 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	1 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=33 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	1 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	2 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	3 Participants n=97 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=7 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=33 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	0 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	0 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	0 Participants n=97 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.
Race (NIH/OMB) Black or African American	1 Participants n=8 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=7 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	1 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=33 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	1 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	0 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	1 Participants n=97 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.
Race (NIH/OMB) White	7 Participants n=8 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	7 Participants n=7 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	3 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	6 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	33 Participants n=33 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	29 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	29 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	91 Participants n=97 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.
Race (NIH/OMB) More than one race	0 Participants n=8 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=7 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=33 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	0 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	0 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	0 Participants n=97 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=7 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=6 Participants • Main Phase Stage 1 reported separately from Main Phase Stage 2.	0 Participants n=33 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	1 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	1 Participants n=32 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.	2 Participants n=97 Participants • Main Phase Stage 2 reported separately from Main Phase Stage 1.

PRIMARY outcome

Timeframe: Up until and including completion of 6 cycles. Each cycle is 28 days.

Population: The all treated population included all participants who received at least one dose of RO7490667.

ORR was defined as the percent of participants with a response according to the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria. This was defined as those participants who achieved clinical improvement (CI), partial remission (PR), or complete remission (CR) at a post-baseline assessment of treatment response OR had at least stable disease (SD) for three consecutive end-of-cycle response assessments (e.g. Day 1 of the subsequent cycle) in conjunction with improvement in the bone marrow fibrosis score relative to baseline by at least one grade at any time point during the period of stable disease.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 1 Main Phase: Overall Response Rate (ORR)	—	37.5 Percentage of Participants Interval 11.11 to 71.08	14.3 Percentage of Participants Interval 0.73 to 52.07	33.3 Percentage of Participants Interval 6.28 to 72.87	50.0 Percentage of Participants Interval 15.32 to 84.68	—	—	—	—	—

PRIMARY outcome

Timeframe: Up until and including completion of 9 cycles. Each cycle is 28 days.

Population: The all treated population included all participants randomized and who received at least one administration of the drug.

Response rate was defined as the percent of participants with a reduction in bone marrow fibrosis by at least one grade according to World Health Organization (WHO) criteria from baseline to any time during the study. This was determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=33 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=32 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=32 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 2 Main Phase: Bone Marrow Response Rate (BMRR)	—	30.3 Percentage of Participants Interval 14.62 to 45.98	31.3 Percentage of Participants Interval 15.19 to 47.31	25.0 Percentage of Participants Interval 10.0 to 40.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From cycle 1 day 1 up until cycle 6, day 29 (Main Phase). From cycle 7 day 1 up until study discontinuation or study termination, up to 83 cycles (OLE). Each cycle is 28 days.

Population: The all treated population (main phase + OLE) included all participants who received at least one dose of RO7490667.

ORR was defined as the percent of participants with a response according to the IWG-MRT criteria. This was defined as those participants who achieved CI, PR, or CR at a post-baseline assessment of treatment response OR had at least SD for three consecutive end-of-cycle response assessments (e.g. Day 1 of the subsequent cycle) in conjunction with improvement in the bone marrow fibrosis score relative to baseline by at least one grade at any time point during the period of stable disease. Participants who achieved a clinical benefit in the main phase had the opportunity to remain on treatment. The determination of ORR in the main phase is outlined in the arms description below. Participants who didn't achieve a benefit had the opportunity to switch to a different dosing schedule in the OLE phase. The determination of ORR in the OLE phase is outlined in the arms descriptions below.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 1 Main + Open-Label Extension (OLE): ORR	—	50.0 Percentage of Participants Interval 19.29 to 80.71	71.4 Percentage of Participants Interval 34.13 to 94.66	50.0 Percentage of Participants Interval 15.32 to 84.68	66.7 Percentage of Participants Interval 27.13 to 93.72	—	—	—	—	—

PRIMARY outcome

Timeframe: From cycle 1 day 1 up until cycle 9 day 29 (main phase). From cycle 10 day 1 up until study discontinuation or study termination, up to 51 cycles (OLE). Each cycle is 28 days.

Population: The all treated population (main phase + OLE) included all participants randomized and who received at least one administration of the drug.

Defined as the percent of participants with a reduction in bone marrow fibrosis score by at least one grade according to WHO criteria at any time during the study. As determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy. Participants in the main phase had the opportunity to remain on treatment (as outlined in the arms description below). Participants also had the option to switch to the OLE phase after completing 9 cycles of the originally assigned treatment and receive PRM-151 10 mg/kg/Q4W (as outlined in the arms description below).

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=33 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=32 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=32 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 2 Main + Open-Label Extension (OLE): BMRR	—	30.3 Percentage of Participants Interval 14.62 to 45.98	34.4 Percentage of Participants Interval 17.92 to 50.83	25.0 Percentage of Participants Interval 10.0 to 40.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12 and 24

Population: The all treated population included all participants who received at least one dose of RO7490667.

Bone marrow response was defined as a reduction in bone marrow fibrosis score by at least one grade from baseline at anytime during the study.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 1 Main Phase: BMRR	—	37.5 Percentage of Participants Interval 3.95 to 71.05	14.3 Percentage of Participants Interval 0.0 to 40.21	16.7 Percentage of Participants Interval 0.0 to 46.49	50.0 Percentage of Participants Interval 9.99 to 90.01	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, beginning of each cycle (Cycle 2 onward). Each cycle is 28 days.

Population: The all treated population included all participants who received at least one dose of RO7490667.

The MPN-SAF TSS total symptom score was the sum of the following 10 items: Filling up quickly when you eat (early satiety), abdominal discomfort, inactivity, Problems with concentration, Worst fatigue, Night sweats, Itching, Bone pain, Fever and Unintentional weight loss last 6 months. The MPN-SAF Total Symptom Score had a possible range of 0 to 100, where a lower score was more favorable. The values reported are the change from baseline scores.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 1 Main Phase: Modified Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Changes C5D1	—	-13.2 Score on a scale Standard Deviation 13.2	2.6 Score on a scale Standard Deviation 6.9	-6.7 Score on a scale Standard Deviation 10.6	1.5 Score on a scale Standard Deviation 13.6	—	—	—	—	—
Stage 1 Main Phase: Modified Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Changes Baseline	—	23.1 Score on a scale Standard Deviation 19.1	16.9 Score on a scale Standard Deviation 7.2	26.8 Score on a scale Standard Deviation 17.1	15.3 Score on a scale Standard Deviation 10.4	—	—	—	—	—
Stage 1 Main Phase: Modified Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Changes Cycle(C)2 Day(D)1	—	-5.3 Score on a scale Standard Deviation 12.6	5.7 Score on a scale Standard Deviation 11.8	0.5 Score on a scale Standard Deviation 8.8	-2.0 Score on a scale Standard Deviation 5.0	—	—	—	—	—
Stage 1 Main Phase: Modified Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Changes C3D1	—	-9.1 Score on a scale Standard Deviation 10.9	1.9 Score on a scale Standard Deviation 5.3	-2.7 Score on a scale Standard Deviation 14.8	4.2 Score on a scale Standard Deviation 8.0	—	—	—	—	—
Stage 1 Main Phase: Modified Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Changes C4D1	—	-8.7 Score on a scale Standard Deviation 10.7	1.0 Score on a scale Standard Deviation 8.0	-7.5 Score on a scale Standard Deviation 6.0	5.7 Score on a scale Standard Deviation 20.9	—	—	—	—	—
Stage 1 Main Phase: Modified Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Changes C6D1	—	-12.2 Score on a scale Standard Deviation 9.5	-0.8 Score on a scale Standard Deviation 8.3	-5.4 Score on a scale Standard Deviation 6.2	4.3 Score on a scale Standard Deviation 11.5	—	—	—	—	—
Stage 1 Main Phase: Modified Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Changes C6D29	—	-15.0 Score on a scale Standard Deviation 13.7	-2.2 Score on a scale Standard Deviation 5.3	-5.3 Score on a scale Standard Deviation 4.6	2.3 Score on a scale Standard Deviation 8.8	—	—	—	—	—

SECONDARY outcome

Timeframe: Up until and including completion of 9 cycles. Each cycle is 28 days.

Population: The all treated population included all participants randomized and who received at least one administration of the drug.

Response rate was defined as the percent of participants with a reduction in bone marrow fibrosis by at least one grade according to World Health Organization (WHO) criteria at any time during the study. This was determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=33 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=32 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=32 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 2 Main Phase: BMRR	—	30.3 Percentage of Participants Interval 14.62 to 45.98	31.3 Percentage of Participants Interval 15.19 to 47.31	25.0 Percentage of Participants Interval 10.0 to 40.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 on Cycles 4, 7, 10 and Cycle 9 Day 29. Each cycle is 28 days.

Population: The all treated population included all participants randomized and who received at least one administration of the drug.

Reduction in bone marrow fibrosis score: Reduction of at least one grade from baseline. Bone marrow fibrosis grades according to WHO criteria (as determined by central adjudication).

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=33 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=32 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=32 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 2 Main Phase: BMRR - Reduction of Bone Marrow Fibrosis by Visit Cycle(C) 4 Day(D) 1	—	10.7 Percentage of Participants	24.0 Percentage of Participants	19.2 Percentage of Participants	—	—	—	—	—	—
Stage 2 Main Phase: BMRR - Reduction of Bone Marrow Fibrosis by Visit C7D1	—	23.8 Percentage of Participants	11.8 Percentage of Participants	10.5 Percentage of Participants	—	—	—	—	—	—
Stage 2 Main Phase: BMRR - Reduction of Bone Marrow Fibrosis by Visit C9D29/C10D1	—	30.0 Percentage of Participants	21.4 Percentage of Participants	13.3 Percentage of Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first decrease from baseline of one grade to time of return to baseline levels, up to cycle 9 of 28-day cycles.

Population: The all treated population included all participants randomized and who received at least one administration of the drug.

Duration of response was defined as time from first decrease from baseline >= 1 grade to time of return to baseline levels.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=33 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=32 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=32 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 2 Main Phase: Duration of Bone Marrow Improvement	—	NA Weeks Interval 12.0 to Data was not evaluable as the participants who had bone marrow improvement but did not return to baseline levels at the end of main phase were censored at their last bone marrow assessment in the main phase (the last timepoint in the main phase at which the improvement was still observed).	12.0 Weeks Interval 12.0 to Data was not evaluable as the participants who had bone marrow improvement but did not return to baseline levels at the end of main phase were censored at their last bone marrow assessment in the main phase (the last timepoint in the main phase at which the improvement was still observed).	12.1 Weeks Interval 11.4 to 13.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up until and including completion of 9 cycles. Each cycle is 28 days.

Population: The all treated population included all participants randomized and who received at least one administration of the drug.

Hemoglobin improvement was measured by the percent of participants with: Red cell transfusion independence (no transfusions for >= 12 consecutive weeks) OR 50% reduction in red blood cell (RBC) transfusions for >= 12 consecutive weeks OR percent of participants with >= 10 g/L and >= 20 g/L increase in hemoglobin for >= 12 consecutive weeks without transfusions (outcome parameter assessed was dependent on baseline hemoglobin/transfusion status).

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=33 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=32 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=32 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 2 Main Phase: Hemoglobin Improvement	—	15.2 Percentage of Participants	15.6 Percentage of Participants	6.3 Percentage of Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up until and including completion of 9 cycles. Each cycle is 28 days.

Population: The all treated population included all participants randomized and who received at least one administration of the drug.

Platelet improvement was measured by the percent of participants with: Platelet transfusion independence (no transfusions for >= 12 consecutive weeks) OR 50% reduction in platelets transfusions for >= 12 consecutive weeks OR doubling of baseline platelet count for >= 12 consecutive weeks without platelet transfusions OR platelet count > 50 x 10e9/L for >=12 consecutive weeks without platelet transfusions OR doubling of baseline platelet count for >= 12 consecutive weeks without platelet transfusions OR platelet count > 25 x 10e9/L for >= 12 consecutive weeks without platelet transfusions (outcome parameter assessed is dependent on baseline platelet status).

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=33 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=32 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=32 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 2 Main Phase: Platelet Improvement	—	27.3 Percentage of Participants	34.4 Percentage of Participants	37.5 Percentage of Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up until and including completion of 9 cycles. Each cycle is 28 days.

Population: The all treated population included all participants randomized and who received at least one administration of the drug.

Symptom improvement was assessed as the percent of participants with 50% reduction in MPN-SAF TSS from baseline over time. The MPN-SAF TSS total symptom score was the sum of the following 10 items: Filling up quickly when you eat (early satiety), abdominal discomfort, inactivity, Problems with concentration, Worst fatigue, Night sweats, Itching, Bone pain, Fever and Unintentional weight loss last 6 months. The MPN-SAF Total Symptom Score had a possible range of 0 to 100, where a lower score was more favorable.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=33 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=32 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=32 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 2 Main Phase: Symptom Improvement C7D1	—	8 Participants	5 Participants	0 Participants	—	—	—	—	—	—
Stage 2 Main Phase: Symptom Improvement Cycle(C) 2 Day(D) 1	—	5 Participants	2 Participants	1 Participants	—	—	—	—	—	—
Stage 2 Main Phase: Symptom Improvement C3D1	—	6 Participants	3 Participants	2 Participants	—	—	—	—	—	—
Stage 2 Main Phase: Symptom Improvement C4D1	—	3 Participants	4 Participants	2 Participants	—	—	—	—	—	—
Stage 2 Main Phase: Symptom Improvement C5D1	—	5 Participants	2 Participants	1 Participants	—	—	—	—	—	—
Stage 2 Main Phase: Symptom Improvement C6D1	—	8 Participants	3 Participants	3 Participants	—	—	—	—	—	—
Stage 2 Main Phase: Symptom Improvement C8D1	—	5 Participants	3 Participants	0 Participants	—	—	—	—	—	—
Stage 2 Main Phase: Symptom Improvement C9D1	—	5 Participants	3 Participants	1 Participants	—	—	—	—	—	—
Stage 2 Main Phase: Symptom Improvement C9D29/C10D1	—	5 Participants	2 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up until and including completion of 9 cycles. Each cycle is 28 days.

Population: The all treated population included all participants randomized and who received at least one administration of the drug.

Best Overall Response: (CR, PR, CI), SD and PD according to the IWG-MRT Criteria.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=33 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=32 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=32 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 2 Main Phase: Percentage of Participants With Complete Response (CR), Partial Response (PR), Clinical Improvement (CI), Stable Disease (SD), and Progressive Disease (PD) According to IWG-MRT Criteria SD	—	20 Participants	21 Participants	26 Participants	—	—	—	—	—	—
Stage 2 Main Phase: Percentage of Participants With Complete Response (CR), Partial Response (PR), Clinical Improvement (CI), Stable Disease (SD), and Progressive Disease (PD) According to IWG-MRT Criteria PD	—	3 Participants	3 Participants	4 Participants	—	—	—	—	—	—
Stage 2 Main Phase: Percentage of Participants With Complete Response (CR), Partial Response (PR), Clinical Improvement (CI), Stable Disease (SD), and Progressive Disease (PD) According to IWG-MRT Criteria CR	—	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Stage 2 Main Phase: Percentage of Participants With Complete Response (CR), Partial Response (PR), Clinical Improvement (CI), Stable Disease (SD), and Progressive Disease (PD) According to IWG-MRT Criteria PR	—	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Stage 2 Main Phase: Percentage of Participants With Complete Response (CR), Partial Response (PR), Clinical Improvement (CI), Stable Disease (SD), and Progressive Disease (PD) According to IWG-MRT Criteria CI	—	8 Participants	6 Participants	2 Participants	—	—	—	—	—	—
Stage 2 Main Phase: Percentage of Participants With Complete Response (CR), Partial Response (PR), Clinical Improvement (CI), Stable Disease (SD), and Progressive Disease (PD) According to IWG-MRT Criteria Not evaluable	—	2 Participants	2 Participants	0 Participants	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days

Population: The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.

Cmax is the maximum observed RO7490677 plasma concentration.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 1 Main Phase: Maximum Drug Concentration (Cmax) C1D1	—	133 Micrograms per Milliliter (ug/mL) Geometric Coefficient of Variation 48.4	113 Micrograms per Milliliter (ug/mL) Geometric Coefficient of Variation 28.1	164 Micrograms per Milliliter (ug/mL) Geometric Coefficient of Variation 23.9	112 Micrograms per Milliliter (ug/mL) Geometric Coefficient of Variation 90.4	—	—	—	—	—
Stage 1 Main Phase: Maximum Drug Concentration (Cmax) C1D15	—	127 Micrograms per Milliliter (ug/mL) Geometric Coefficient of Variation 31.9	—	126 Micrograms per Milliliter (ug/mL) Geometric Coefficient of Variation 27.5	—	—	—	—	—	—
Stage 1 Main Phase: Maximum Drug Concentration (Cmax) C2D1	—	107 Micrograms per Milliliter (ug/mL) Geometric Coefficient of Variation 26.9	110 Micrograms per Milliliter (ug/mL) Geometric Coefficient of Variation 20.9	149 Micrograms per Milliliter (ug/mL) Geometric Coefficient of Variation 29.1	130 Micrograms per Milliliter (ug/mL) Geometric Coefficient of Variation 80.2	—	—	—	—	—
Stage 1 Main Phase: Maximum Drug Concentration (Cmax) C6D1	—	142 Micrograms per Milliliter (ug/mL) Geometric Coefficient of Variation 70.0	111 Micrograms per Milliliter (ug/mL) Geometric Coefficient of Variation 28.0	136 Micrograms per Milliliter (ug/mL) Geometric Coefficient of Variation 34.1	142 Micrograms per Milliliter (ug/mL) Geometric Coefficient of Variation 27.4	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days

Population: The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.

Time at which the maximum plasma concentration was observed.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 1 Main Phase: Time to Maximum Concentration (Tmax) C6D1	—	2.00 Hour (hr) Interval 1.03 to 5.2	1.07 Hour (hr) Interval 1.0 to 2.03	1.17 Hour (hr) Interval 1.05 to 5.0	1.01 Hour (hr) Interval 1.0 to 1.08	—	—	—	—	—
Stage 1 Main Phase: Time to Maximum Concentration (Tmax) C1D1	—	1.12 Hour (hr) Interval 1.0 to 2.0	1.10 Hour (hr) Interval 1.0 to 2.08	1.14 Hour (hr) Interval 1.0 to 2.25	1.13 Hour (hr) Interval 1.0 to 5.0	—	—	—	—	—
Stage 1 Main Phase: Time to Maximum Concentration (Tmax) C1D15	—	1.13 Hour (hr) Interval 1.03 to 1.8	—	1.65 Hour (hr) Interval 1.02 to 2.5	—	—	—	—	—	—
Stage 1 Main Phase: Time to Maximum Concentration (Tmax) C2D1	—	1.10 Hour (hr) Interval 1.0 to 3.17	1.08 Hour (hr) Interval 1.03 to 1.08	1.05 Hour (hr) Interval 1.0 to 1.32	1.44 Hour (hr) Interval 1.0 to 9.0	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days

Population: The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.

Area under the plasma concentration time curve from time 0 to time of last measurable plasma concentration.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 1 Main Phase: Area Under the Curve up to the Last Measurable Concentration (AUC0-last) C1D1	—	1810 ug*hour/mL Geometric Coefficient of Variation 72.0	1690 ug*hour/mL Geometric Coefficient of Variation 26.1	2590 ug*hour/mL Geometric Coefficient of Variation 28.7	1500 ug*hour/mL Geometric Coefficient of Variation 158.3	—	—	—	—	—
Stage 1 Main Phase: Area Under the Curve up to the Last Measurable Concentration (AUC0-last) C1D15	—	1460 ug*hour/mL Geometric Coefficient of Variation 142.0	—	2590 ug*hour/mL Geometric Coefficient of Variation 187.6	—	—	—	—	—	—
Stage 1 Main Phase: Area Under the Curve up to the Last Measurable Concentration (AUC0-last) C2D1	—	127.3 ug*hour/mL Geometric Coefficient of Variation 904	504 ug*hour/mL Geometric Coefficient of Variation 84.7	2990 ug*hour/mL Geometric Coefficient of Variation 92.0	663 ug*hour/mL Geometric Coefficient of Variation 79.5	—	—	—	—	—
Stage 1 Main Phase: Area Under the Curve up to the Last Measurable Concentration (AUC0-last) C6D1	—	698 ug*hour/mL Geometric Coefficient of Variation 63.0	570 ug*hour/mL Geometric Coefficient of Variation 44.8	764 ug*hour/mL Geometric Coefficient of Variation 28.9	703 ug*hour/mL Geometric Coefficient of Variation 33.8	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days

Population: The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.

Area under the plasma concentration-time curve from 0-time extrapolated to infinity.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 1 Main Phase: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) C1D1	—	2830 ug*hour/mL Geometric Coefficient of Variation 12.9	2050 ug*hour/mL Geometric Coefficient of Variation 29.5	2970 ug*hour/mL Geometric Coefficient of Variation 34.9	3130 ug*hour/mL Geometric Coefficient of Variation 8.6	—	—	—	—	—
Stage 1 Main Phase: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) C1D15	—	3450 ug*hour/mL Geometric Coefficient of Variation 2.8	—	6060 ug*hour/mL Geometric Coefficient of Variation 23.2	—	—	—	—	—	—
Stage 1 Main Phase: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) C2D1	—	2170 ug*hour/mL Geometric Coefficient of Variation 170.9	—	4230 ug*hour/mL Geometric Coefficient of Variation 34.8	—	—	—	—	—	—
Stage 1 Main Phase: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) C6D1	—	—	—	819 ug*hour/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated from data for a single participant.	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days

Population: The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.

Apparent terminal elimination half-life of RO7490677.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 1 Main Phase: Terminal Elimination Half-Life (T1/2) C1D15	—	31.2 hr Geometric Coefficient of Variation 45.0	—	40.4 hr Geometric Coefficient of Variation 12.6	—	—	—	—	—	—
Stage 1 Main Phase: Terminal Elimination Half-Life (T1/2) C2D1	—	18.0 hr Geometric Coefficient of Variation 220.6	—	30.0 hr Geometric Coefficient of Variation 48.6	—	—	—	—	—	—
Stage 1 Main Phase: Terminal Elimination Half-Life (T1/2) C6D1	—	—	—	1.95 hr Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated from data for a single participant.	—	—	—	—	—	—
Stage 1 Main Phase: Terminal Elimination Half-Life (T1/2) C1D1	—	14.7 hr Geometric Coefficient of Variation 19.2	17.2 hr Geometric Coefficient of Variation 23.7	16.8 hr Geometric Coefficient of Variation 17.7	18.4 hr Geometric Coefficient of Variation 7.9	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days

Population: The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 1 Main Phase: Clearance (CL) C1D1	—	0.258 Litres per hour (L/hr) Geometric Coefficient of Variation 9.0	0.362 Litres per hour (L/hr) Geometric Coefficient of Variation 31.5	0.269 Litres per hour (L/hr) Geometric Coefficient of Variation 32.9	0.233 Litres per hour (L/hr) Geometric Coefficient of Variation 33.3	—	—	—	—	—
Stage 1 Main Phase: Clearance (CL) C1D15	—	0.233 Litres per hour (L/hr) Geometric Coefficient of Variation 24.9	—	0.147 Litres per hour (L/hr) Geometric Coefficient of Variation 35.0	—	—	—	—	—	—
Stage 1 Main Phase: Clearance (CL) C2D1	—	0.382 Litres per hour (L/hr) Geometric Coefficient of Variation 229.9	—	0.189 Litres per hour (L/hr) Geometric Coefficient of Variation 55.5	—	—	—	—	—	—
Stage 1 Main Phase: Clearance (CL) C6D1	—	—	—	1.42 Litres per hour (L/hr) Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated from data for a single participant.	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days

Population: The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Stage 1 Main Phase: Volume of Distribution (Vd) C1D1	—	5.47 Litres (L) Geometric Coefficient of Variation 10.9	9.00 Litres (L) Geometric Coefficient of Variation 28.8	6.52 Litres (L) Geometric Coefficient of Variation 26.4	6.17 Litres (L) Geometric Coefficient of Variation 38.9	—	—	—	—	—
Stage 1 Main Phase: Volume of Distribution (Vd) C1D15	—	10.5 Litres (L) Geometric Coefficient of Variation 62.4	—	8.57 Litres (L) Geometric Coefficient of Variation 47.6	—	—	—	—	—	—
Stage 1 Main Phase: Volume of Distribution (Vd) C2D1	—	9.93 Litres (L) Geometric Coefficient of Variation 63.0	—	8.18 Litres (L) Geometric Coefficient of Variation 24.5	—	—	—	—	—	—
Stage 1 Main Phase: Volume of Distribution (Vd) C6D1	—	—	—	4.01 Litres (L) Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated from data for a single participant.	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up until 6.75 years

Population: The safety population included all participants who received at least one dose of study drug.

An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product-related. Pre-existing conditions which worsened during the study were also considered as adverse events. IRRs were considerd to be Adverse Events of Special Interest (AESI). Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W n=48 Participants Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W n=33 Participants Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W n=32 Participants Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W n=32 Participants Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=13 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=5 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Percentage of Participants With Adverse Events (AEs) and Infusion Related Reactions (IRRs) AEs	89.6 Percentage of Participants	100 Percentage of Participants	85.7 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants	92.3 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Adverse Events (AEs) and Infusion Related Reactions (IRRs) IRRs	2.1 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	16.7 Percentage of Participants	3.0 Percentage of Participants	3.1 Percentage of Participants	6.3 Percentage of Participants	7.7 Percentage of Participants	20.0 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up until 6.75 years

Population: The safety population included all participants who received at least one dose of study drug.

An SAE was defined as any AE that occurred at any dose the resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalizations; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly or birth defect. An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product-related. Pre-existing conditions which worsened during the study were also considered as adverse events. Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.

Outcome measures

Measure	OLE Stage 2: RO7490677 10 mg/kg IV Q4W n=48 Participants Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 Participants Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W n=33 Participants Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W n=32 Participants Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W n=32 Participants Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=13 Participants Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=5 Participants Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.
Percentage of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation SAEs	22.9 Percentage of Participants	25.0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	15.2 Percentage of Participants	15.6 Percentage of Participants	28.1 Percentage of Participants	7.7 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation AEs	27.1 Percentage of Participants	25.0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	21.2 Percentage of Participants	34.4 Percentage of Participants	37.5 Percentage of Participants	30.8 Percentage of Participants	0 Percentage of Participants

Adverse Events

Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)

Serious events: 2 serious events

Other events: 8 other events

Deaths: 2 deaths

Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W

Serious events: 11 serious events

Other events: 32 other events

Deaths: 7 deaths

Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W

Serious events: 14 serious events

Other events: 30 other events

Deaths: 6 deaths

Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W

Serious events: 14 serious events

Other events: 31 other events

Deaths: 9 deaths

OLE Stage 1: RO7490677 10 mg/kg IV Q4W

Serious events: 5 serious events

Other events: 12 other events

Deaths: 0 deaths

OLE Stage 1: RO7490677 10 mg/kg IV Q4W + Ruxolitinib

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

OLE Stage 2: RO7490677 10 mg/kg IV Q4W

Serious events: 22 serious events

Other events: 32 other events

Deaths: 7 deaths

Serious adverse events

Measure	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 participants at risk Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 participants at risk Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 participants at risk Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 participants at risk Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W n=33 participants at risk Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W n=32 participants at risk Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W n=32 participants at risk Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W n=13 participants at risk Participants who completed the main phase of treatment moved to the open label extension. They were treated with single agent PRM-151 at a dose of 10 mg/kg administered as an IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W + Ruxolitinib n=5 participants at risk Participants who completed the main phase of treatment moved to the open label extension. They were treated with PRM-151 at a dose of 10 mg/kg administered as an IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.	OLE Stage 2: RO7490677 10 mg/kg IV Q4W n=48 participants at risk Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Nervous system disorders Syncope	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Renal and urinary disorders Acute kidney injury	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Renal and urinary disorders Nephrolithiasis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Surgical and medical procedures Aortic valve replacement	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Vascular disorders Dry gangrene	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Cardiac disorders Cardiac arrest	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Organ failure	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Hepatobiliary disorders Portal hypertension	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Enterocolitis infectious	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Gastroenteritis	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Pneumonia viral	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Sialoadenitis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Wound infection	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Post procedural haematoma	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Renal and urinary disorders Renal failure	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Nervous system disorders Metabolic encephalopathy	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Renal and urinary disorders Urinary bladder rupture	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Vascular disorders Haematoma	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations Hepatic enzyme increased	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.3% 1/7 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Infection	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Pneumonia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Blood and lymphatic system disorders Anaemia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	4.2% 2/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Blood and lymphatic system disorders Extramedullary haemopoiesis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Cardiac disorders Acute coronary syndrome	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Cardiac disorders Acute myocardial infarction	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Cardiac disorders Aortic valve stenosis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Cardiac disorders Cardiac failure	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Cardiac disorders Cardiopulmonary failure	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Cardiac disorders Coronary artery disease	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Cardiac disorders Pericardial effusion	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Femoral hernia, obstructive	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Melaena	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Varices oesophageal	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Asthenia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Chest pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Death	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Disease progression	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Inflammation	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Peripheral swelling	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Unevaluable event	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Hepatobiliary disorders Cholecystitis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Hepatobiliary disorders Cholelithiasis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Immune system disorders Anaphylactic reaction	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Abscess limb	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Cellulitis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Endocarditis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Influenza	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Intervertebral discitis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Osteomyelitis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	4.2% 2/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Pneumonia fungal	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Pseudomonal sepsis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Sepsis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Septic shock	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Urinary tract infection	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Urosepsis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Fall	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Osteoradionecrosis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations Eastern Cooperative Oncology Group performance status worsened	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Metabolism and nutrition disorders Cachexia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	4.2% 2/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Primary myelofibrosis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transformation to acute myeloid leukaemia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Nervous system disorders Cerebral haemorrhage	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Nervous system disorders Hepatic encephalopathy	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.

Other adverse events

Measure	Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) n=8 participants at risk Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) n=7 participants at risk Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib n=6 participants at risk Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib n=6 participants at risk Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.	Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W n=33 participants at risk Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W n=32 participants at risk Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W n=32 participants at risk Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W n=13 participants at risk Participants who completed the main phase of treatment moved to the open label extension. They were treated with single agent PRM-151 at a dose of 10 mg/kg administered as an IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.	OLE Stage 1: RO7490677 10 mg/kg IV Q4W + Ruxolitinib n=5 participants at risk Participants who completed the main phase of treatment moved to the open label extension. They were treated with PRM-151 at a dose of 10 mg/kg administered as an IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.	OLE Stage 2: RO7490677 10 mg/kg IV Q4W n=48 participants at risk Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.
Infections and infestations Cellulitis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	8.3% 4/48 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Folliculitis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Eye contusion	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Blood and lymphatic system disorders Anaemia	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.2% 5/33 • Number of events 11 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	18.8% 6/32 • Number of events 8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.4% 3/32 • Number of events 6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 6/48 • Number of events 12 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	23.1% 3/13 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.6% 7/48 • Number of events 7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.2% 5/33 • Number of events 6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	4.2% 2/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Abdominal distension	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.1% 3/33 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Abdominal pain	12.5% 1/8 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.2% 5/33 • Number of events 7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	18.8% 6/32 • Number of events 8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Abdominal pain upper	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	23.1% 3/13 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	4.2% 2/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Diarrhoea	25.0% 2/8 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	33.3% 2/6 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	24.2% 8/33 • Number of events 8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.6% 5/32 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.4% 3/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.6% 7/48 • Number of events 7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Nausea	25.0% 2/8 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.3% 1/7 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.6% 5/32 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	30.8% 4/13 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	40.0% 2/5 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Stomatitis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Vomiting	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.3% 1/7 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.6% 5/32 • Number of events 9 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.4% 2/13 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	40.0% 2/5 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Asthenia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.3% 1/7 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	4.2% 2/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Chest pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Chills	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Fatigue	37.5% 3/8 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.3% 1/7 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	24.2% 8/33 • Number of events 9 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	25.0% 8/32 • Number of events 10 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	34.4% 11/32 • Number of events 12 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.4% 2/13 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	10.4% 5/48 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Oedema peripheral	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.3% 1/7 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	18.2% 6/33 • Number of events 8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.4% 3/32 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	28.1% 9/32 • Number of events 10 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.4% 2/13 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	8.3% 4/48 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Peripheral swelling	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	33.3% 2/6 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Pyrexia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	50.0% 3/6 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.1% 4/33 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	21.9% 7/32 • Number of events 8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.4% 3/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	4.2% 2/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Bronchitis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.1% 3/33 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	40.0% 2/5 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Nasopharyngitis	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Oral herpes	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	33.3% 2/6 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Pneumonia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.1% 3/33 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.4% 3/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Sinusitis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Skin infection	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	33.3% 2/6 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	23.1% 3/13 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	4.2% 2/48 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Urinary tract infection	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.4% 2/13 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	8.3% 4/48 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Contusion	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	10.4% 5/48 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations Alanine aminotransferase increased	37.5% 3/8 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	40.0% 2/5 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations Aspartate aminotransferase increased	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.6% 5/32 • Number of events 9 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	40.0% 2/5 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations Blood bilirubin increased	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.3% 1/7 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations Weight increased	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.1% 4/33 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	4.2% 2/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Metabolism and nutrition disorders Gout	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.1% 3/33 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.4% 3/32 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	4.2% 2/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Metabolism and nutrition disorders Hyperuricaemia	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.1% 3/33 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.6% 5/32 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.4% 2/13 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	80.0% 4/5 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.4% 3/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.1% 3/33 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.4% 3/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.1% 3/33 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Muscular weakness	25.0% 2/8 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.3% 1/7 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.1% 3/33 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.3% 1/7 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.6% 5/32 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	60.0% 3/5 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Nervous system disorders Dizziness	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	18.2% 6/33 • Number of events 9 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.4% 3/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	4.2% 2/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Nervous system disorders Headache	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	33.3% 2/6 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.1% 4/33 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	21.9% 7/32 • Number of events 8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.4% 3/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.4% 2/13 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	40.0% 2/5 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Nervous system disorders Hypoaesthesia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Nervous system disorders Neuropathy peripheral	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	28.6% 2/7 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.1% 3/33 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Psychiatric disorders Depression	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Psychiatric disorders Insomnia	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	33.3% 2/6 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	30.3% 10/33 • Number of events 12 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	21.9% 7/32 • Number of events 8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.6% 5/32 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.4% 2/13 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	60.0% 3/5 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	8.3% 4/48 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	28.6% 2/7 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.1% 4/33 • Number of events 7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	25.0% 8/32 • Number of events 10 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	21.9% 7/32 • Number of events 8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	8.3% 4/48 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	33.3% 2/6 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.1% 3/33 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	33.3% 2/6 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	15.2% 5/33 • Number of events 7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 11 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.6% 7/48 • Number of events 16 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.3% 1/7 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.4% 3/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Vascular disorders Hypotension	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Blood and lymphatic system disorders Leukopenia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Blood and lymphatic system disorders Neutropenia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	4.2% 2/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Cardiac disorders Tachycardia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Eye disorders Dry eye	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Constipation	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.1% 4/33 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.5% 4/32 • Number of events 6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Gingival bleeding	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Chest discomfort	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Gait disturbance	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Fall	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.4% 3/32 • Number of events 7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations Blood alkaline phosphatase increased	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	4.2% 2/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations Blood sodium decreased	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations Neutrophil count decreased	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.0% 1/33 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.4% 3/32 • Number of events 4 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations Platelet count decreased	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	12.1% 4/33 • Number of events 8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.4% 3/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations Weight decreased	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	18.2% 6/33 • Number of events 7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	25.0% 8/32 • Number of events 8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	25.0% 8/32 • Number of events 11 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	10.4% 5/48 • Number of events 6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations White blood cell count decreased	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 3/48 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Metabolism and nutrition disorders Cachexia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.1% 2/33 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	9.4% 3/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	4.2% 2/48 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Psychiatric disorders Delirium	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Renal and urinary disorders Dysuria	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	6.2% 2/32 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Cardiac disorders Palpitations	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Endocrine disorders Hypothyroidism	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Eye disorders Vision blurred	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Abdominal pain lower	25.0% 2/8 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Anal incontinence	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Flatulence	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Gingival pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Oral disorder	12.5% 1/8 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Oral pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Gastrointestinal disorders Retching	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Early satiety	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Extravasation	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Ill-defined disorder	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Injection site haemorrhage	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Swelling	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
General disorders Vessel puncture site bruise	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	33.3% 2/6 • Number of events 5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Hepatobiliary disorders Hepatomegaly	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Hepatobiliary disorders Hepatosplenomegaly	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Diarrhoea infectious	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Gastroenteritis viral	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Laryngitis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Localised infection	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Lyme disease	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Rhinitis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.3% 1/7 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Sialoadenitis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Subcutaneous abscess	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Tooth infection	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Urosepsis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.3% 1/7 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Transfusion reaction	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Wound	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations Blood creatine phosphokinase increased	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	40.0% 2/5 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations Blood creatinine increased	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations Blood urea increased	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Investigations Blood uric acid increased	25.0% 2/8 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 3 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Metabolism and nutrition disorders Iron overload	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Joint lock	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Joint swelling	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	2.1% 1/48 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Nervous system disorders Nerve compression	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Nervous system disorders Sciatic nerve neuropathy	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Nervous system disorders Sciatica	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Psychiatric disorders Sleep disorder	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Renal and urinary disorders Haematuria	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Renal and urinary disorders Nocturia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Hypoxia	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	14.3% 1/7 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Hyperhidrosis	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Lichen planus	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 2 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	16.7% 1/6 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	3.1% 1/32 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Social circumstances Blood product transfusion dependent	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Vascular disorders Haematoma	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	7.7% 1/13 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Vascular disorders Hot flush	12.5% 1/8 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/5 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.
Vascular disorders Hypertension	0.00% 0/8 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/7 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/6 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/33 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/32 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/13 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	20.0% 1/5 • Number of events 1 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.	0.00% 0/48 • Baseline up until 6.75 years Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER