Trial Outcomes & Findings for An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis (NCT NCT03385564)

Last Updated: 2022-07-13

Results Overview

The adjusted (model-based, adjusted for race and proteinuria at screening) percentage of patients with complete renal response (CRR) and without any renal flares is reported. A logistic regression model was used including treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening. Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \< 20% from baseline if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

69 participants

Primary outcome timeframe

At Week 52

Results posted on

2022-07-13

Participant Flow

This study was to evaluate long-term efficacy and safety of different doses of BI 655064 versus placebo as add-on therapy to standard of care during maintenance treatment for lupus nephritis.

This is an extension trial with the requirement to entry that subjects responded to treatment in 1293.10 (NCT02770170) and had the desire to continue participation in a clinical trial. Subjects were screened for eligibility prior to participation in trial 1293.10 (NCT02770170).

Participant milestones

Participant milestones
Measure	BI 655064 120 mg 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 180 mg 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Overall Study STARTED	7	15	21	26
Overall Study Intent to Treat Set	7	15	21	26
Overall Study COMPLETED	7	14	16	17
Overall Study NOT COMPLETED	0	1	5	9

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 655064 180 mg 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Overall Study Adverse Event	0	3	3
Overall Study Other than listed	0	0	5
Overall Study Withdrawal by Subject	1	1	0
Overall Study Lack of Efficacy	0	0	1
Overall Study Death	0	1	0

Baseline Characteristics

An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 655064 120 mg n=7 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 180 mg n=15 Participants 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg n=21 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo n=26 Participants Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Total n=69 Participants Total of all reporting groups
Age, Continuous	31.9 Years STANDARD_DEVIATION 6.5 • n=5 Participants	36.5 Years STANDARD_DEVIATION 8.7 • n=7 Participants	35.4 Years STANDARD_DEVIATION 10.5 • n=5 Participants	34.8 Years STANDARD_DEVIATION 10.9 • n=4 Participants	35.1 Years STANDARD_DEVIATION 9.9 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants	24 Participants n=4 Participants	61 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	19 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants	20 Participants n=4 Participants	50 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	11 Participants n=4 Participants	28 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	15 Participants n=4 Participants	38 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: At Week 52

Population: Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis.

Outcome measures

Outcome measures
Measure	BI 655064 120 mg n=7 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 180 mg n=14 Participants 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg n=20 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo n=25 Participants Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Percentage of Patients With Complete Renal Response (CRR) and Without Any Renal Flares	51.83 Percentage of participants	48.15 Percentage of participants	59.49 Percentage of participants	57.51 Percentage of participants

SECONDARY outcome

Timeframe: At Week 52

The percentage of patients with confirmed complete renal response (CRR) (defined as CRR at both Week 42 and Week 52 using urine protein (UP)/urine creatine (UC) ratio \[UP/UC\] from the spot urines) and without any renal flares is reported. Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \< 20% from baseline if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min).

Outcome measures

Outcome measures
Measure	BI 655064 120 mg n=7 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 180 mg n=13 Participants 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg n=20 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo n=25 Participants Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Percentage of Patients With Confirmed Complete Renal Response (CRR) and Without Any Renal Flares	42.9 Percentage of participants	30.8 Percentage of participants	50.0 Percentage of participants	52.0 Percentage of participants

SECONDARY outcome

Timeframe: At Week 52

The percentage of patients with proteinuria \<0.8 grams (g)/day (d) and without any renal flares at week 52 is reported.

Outcome measures

Outcome measures
Measure	BI 655064 120 mg n=7 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 180 mg n=14 Participants 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg n=20 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo n=25 Participants Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Percentage of Patients With Proteinuria <0.8 Grams (g)/Day (d) and Without Any Renal Flares at Week 52	57.1 Percentage of participants	50.0 Percentage of participants	60.0 Percentage of participants	60.0 Percentage of participants

SECONDARY outcome

Timeframe: At Week 52 (Sustained Steroid Reduction to ≤5 mg/d was evaluated from Week 26 to Week 52).

The percentage of patients with complete renal response (CRR) at Week 52 and sustained steroid reduction to ≤5 milligrams (mg)/day (d) from Week 26 to Week 52 is reported. Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \< 20% from baseline if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min.

Outcome measures

Outcome measures
Measure	BI 655064 120 mg n=7 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 180 mg n=14 Participants 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg n=18 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo n=23 Participants Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Percentage of Patients With Complete Renal Response (CRR) at Week 52 and Sustained Steroid Reduction to ≤5 Milligrams (mg)/Day (d) From Week 26 to Week 52	42.9 Percentage of participants	42.9 Percentage of participants	55.6 Percentage of participants	39.1 Percentage of participants

SECONDARY outcome

Timeframe: At Week 52

The percentage of patients experiencing at least one renal flare during 52 weeks is reported.

Outcome measures

Outcome measures
Measure	BI 655064 120 mg n=7 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 180 mg n=14 Participants 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg n=21 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo n=25 Participants Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Percentage of Patients Experiencing at Least One Renal Flare During 52 Weeks	0 Percentage of participants	21.4 Percentage of participants	0 Percentage of participants	16.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 52 weeks.

Population: Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subject with non-missing results were included in the analysis.

The time to first renal flare over the course of 52 weeks is reported.

Outcome measures

Outcome measures
Measure	BI 655064 120 mg 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 180 mg n=3 Participants 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo n=4 Participants Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Time to First Renal Flare Over the Course of 52 Weeks	—	36.0 Weeks Interval 26.0 to 52.0	—	37.5 Weeks Interval 6.0 to 52.0

SECONDARY outcome

Timeframe: At Week 52

The percentage of patients with partial renal response (PRR) and without any renal flares derived from urine protein (UP) 24 hours (h) collection at Week 52 is reported. Partial renal response (PRR) was defined as at least 50% reduction of proteinuria from baseline if estimated glomerular filtration rate (eGFR) was within normal range at time of assessment or decrease of eGFR \<20% from baseline if eGFR was below normal range at time of assessment.

Outcome measures

Outcome measures
Measure	BI 655064 120 mg n=7 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 180 mg n=14 Participants 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg n=20 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo n=25 Participants Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Percentage of Patients With Partial Renal Response (PRR) and Without Any Renal Flares Derived From Urine Protein (UP) 24 Hours (h) Collection at Week 52	100.0 Percentage of participants	64.3 Percentage of participants	75.0 Percentage of participants	68.0 Percentage of participants

SECONDARY outcome

Timeframe: At baseline and at Week 12

Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 12 is reported. Change from baseline at Week 12 is calculated as: value at Week 12 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health).

Outcome measures

Outcome measures
Measure	BI 655064 120 mg n=7 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 180 mg n=13 Participants 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg n=18 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo n=25 Participants Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 12	-8.4 Score on a scale Standard Deviation 5.8	-7.5 Score on a scale Standard Deviation 4.3	-9.3 Score on a scale Standard Deviation 4.9	-7.7 Score on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: At baseline and at Week 26

Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 26 is reported. Change from baseline at Week 26 is calculated as: value at Week 26 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health).

Outcome measures

Outcome measures
Measure	BI 655064 120 mg n=7 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 180 mg n=14 Participants 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg n=16 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo n=21 Participants Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 26	-8.7 Score on a scale Standard Deviation 5.7	-7.9 Score on a scale Standard Deviation 3.5	-11.3 Score on a scale Standard Deviation 4.8	-5.9 Score on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: At baseline and at Week 42

Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 42 is reported. Change from baseline at Week 42 is calculated as: value at Week 42 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health).

Outcome measures

Outcome measures
Measure	BI 655064 120 mg n=5 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 180 mg n=7 Participants 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg n=9 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo n=13 Participants Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 42	-6.6 Score on a scale Standard Deviation 3.4	-6.3 Score on a scale Standard Deviation 2.4	-11.1 Score on a scale Standard Deviation 5.1	-6.5 Score on a scale Standard Deviation 6.7

SECONDARY outcome

Timeframe: At baseline and at Week 52

Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 52 is reported. Change from baseline at Week 52 is calculated as: value at Week 52 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health).

Outcome measures

Outcome measures
Measure	BI 655064 120 mg n=7 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 180 mg n=14 Participants 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg n=16 Participants 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo n=17 Participants Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 52	-8.9 Score on a scale Standard Deviation 6.1	-7.2 Score on a scale Standard Deviation 4.0	-10.6 Score on a scale Standard Deviation 4.9	-5.3 Score on a scale Standard Deviation 8.0

Adverse Events

BI 655064 120 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

BI 655064 180 mg

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

BI 655064 240 mg

Serious events: 6 serious events

Other events: 15 other events

Deaths: 1 deaths

Placebo

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	BI 655064 120 mg n=7 participants at risk 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 180 mg n=15 participants at risk 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg n=21 participants at risk 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo n=26 participants at risk Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	3.8% 1/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Cardiac disorders Arrhythmia	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Endocrine disorders Adrenal insufficiency	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Gastrointestinal disorders Ascites	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Gastrointestinal disorders Ileus	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Gastrointestinal disorders Nausea	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
General disorders Pyrexia	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Hepatobiliary disorders Haemobilia	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	3.8% 1/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Immune system disorders Haemophagocytic lymphohistiocytosis	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	3.8% 1/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Clostridium difficile infection	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Meningitis enterococcal	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Nocardiosis	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Pelvic abscess	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Pyelonephritis acute	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	6.7% 1/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Tuberculosis of central nervous system	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	6.7% 1/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Musculoskeletal and connective tissue disorders Crystal arthropathy	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	3.8% 1/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ocular lymphoma	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Nervous system disorders Peripheral sensorimotor neuropathy	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Renal and urinary disorders Nephrolithiasis	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	3.8% 1/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	3.8% 1/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.

Other adverse events
Measure	BI 655064 120 mg n=7 participants at risk 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 180 mg n=15 participants at risk 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	BI 655064 240 mg n=21 participants at risk 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.	Placebo n=26 participants at risk Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Immune system disorders Allergy to arthropod bite	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	6.7% 1/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations COVID-19	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	3.8% 1/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	7.7% 2/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Ear and labyrinth disorders Ear pain	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Ear and labyrinth disorders Vertigo	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	3.8% 1/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Eye disorders Cataract	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Eye disorders Photopsia	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Eye disorders Visual field defect	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Gastrointestinal disorders Abdominal pain	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	6.7% 1/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Gastrointestinal disorders Diarrhoea	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	20.0% 3/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	7.7% 2/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	6.7% 1/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Gastrointestinal disorders Mouth ulceration	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	7.7% 2/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Gastrointestinal disorders Nausea	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
General disorders Asthenia	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
General disorders Chest pain	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
General disorders Chills	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
General disorders Oedema	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	6.7% 1/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Coronavirus infection	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	6.7% 1/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Herpes simplex	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	3.8% 1/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Herpes zoster	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Nasopharyngitis	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Periodontitis	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Pharyngitis	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	6.7% 1/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Respiratory tract infection	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	3.8% 1/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Rhinitis	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	6.7% 1/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Tonsillitis	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Upper respiratory tract infection	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	20.0% 3/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	23.8% 5/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	11.5% 3/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Urinary tract infection	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	6.7% 1/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	14.3% 3/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	11.5% 3/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Infections and infestations Vaginal infection	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	6.7% 1/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Injury, poisoning and procedural complications Chillblains	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	6.7% 1/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	6.7% 1/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	3.8% 1/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Investigations Alanine aminotransferase increased	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	9.5% 2/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	3.8% 1/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Investigations Blood creatine phosphokinase increased	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	3.8% 1/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Investigations Blood lactate dehydrogenase decreased	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Investigations Urine protein/creatinine ratio increased	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	13.3% 2/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	3.8% 1/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Investigations Weight increased	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	7.7% 2/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Metabolism and nutrition disorders Dyslipidaemia	14.3% 1/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	6.7% 1/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	0.00% 0/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/7 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	6.7% 1/15 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	4.8% 1/21 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.	3.8% 1/26 • For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks. Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.