Trial Outcomes & Findings for Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (NCT NCT02770170)
NCT ID: NCT02770170
Last Updated: 2025-10-16
Results Overview
Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day at Week 52 and either estimated glomerular filtration rate (eGFR) within normal range at Week 52 or decrease in eGFR \< 20% from baseline at Week 52 if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min). CRR at Week 52 (derived using UP from the 24 h urine collections) was analyzed using a logistic regression model. Factors in the model included treatment and the covariates race (Asian/Non-Asian) and proteinuria at screening (UP/urine creatinine (UC) \<3 or \>=3 g/day). Pairwise comparisons of the modelled proportions of patients with CRR at each dose level to placebo were performed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
At week 52.
Results posted on
2025-10-16
Participant Flow
This is a double-blind, randomised, placebo-controlled trial evaluating the effect of BI 655064 administered as subcutaneous injections, on renal response after one year of treatment, in patients with active lupus nephritis.
All patients were screened for eligibility prior to participation in the trial. Patients attended a specialist site which ensured that they (the patients) strictly met all inclusion and none of the exclusion criteria. Patients were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
120 mg BI 655064
Participants in dose group 1 received two subcutaneous injections per week, one of 120 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
180 mg BI 655064
Participants in dose group 2 received two subcutaneous injections per week, one of 180 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 180 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
240 mg BI 655064
Participants in dose group 3 received two subcutaneous injections per week of 120 milligrams (mg) of BI 655064 (240 mg in total) on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064, up to 52 weeks.
|
Placebo
Participants in the placebo group received two subcutaneous injections per week of placebo on the same day for 3 weeks followed by one subcutaneous injection per week of placebo, up to 52 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
40
|
40
|
|
Overall Study
COMPLETED
|
14
|
17
|
35
|
33
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
5
|
7
|
Reasons for withdrawal
| Measure |
120 mg BI 655064
Participants in dose group 1 received two subcutaneous injections per week, one of 120 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
180 mg BI 655064
Participants in dose group 2 received two subcutaneous injections per week, one of 180 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 180 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
240 mg BI 655064
Participants in dose group 3 received two subcutaneous injections per week of 120 milligrams (mg) of BI 655064 (240 mg in total) on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064, up to 52 weeks.
|
Placebo
Participants in the placebo group received two subcutaneous injections per week of placebo on the same day for 3 weeks followed by one subcutaneous injection per week of placebo, up to 52 weeks.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
|
Overall Study
due to pregnancy
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
4
|
3
|
5
|
3
|
|
Overall Study
due to disease worsening
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis
Baseline characteristics by cohort
| Measure |
120 mg BI 655064
n=21 Participants
Participants in dose group 1 received two subcutaneous injections per week, one of 120 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
180 mg BI 655064
n=20 Participants
Participants in dose group 2 received two subcutaneous injections per week, one of 180 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 180 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
240 mg BI 655064
n=40 Participants
Participants in dose group 3 received two subcutaneous injections per week of 120 milligrams (mg) of BI 655064 (240 mg in total) on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064, up to 52 weeks.
|
Placebo
n=40 Participants
Participants in the placebo group received two subcutaneous injections per week of placebo on the same day for 3 weeks followed by one subcutaneous injection per week of placebo, up to 52 weeks.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
97 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
|
|
Age, Continuous
|
35.9 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
34.5 Years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
34.3 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
33.9 Years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
34.5 Years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
108 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
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
52 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
63 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
|
|
estimated glomerular filtration rate (eGFR) at baseline
|
85.857 mL/min/1.73 m²
STANDARD_DEVIATION 34.268 • n=5 Participants
|
99.850 mL/min/1.73 m²
STANDARD_DEVIATION 21.109 • n=7 Participants
|
91.125 mL/min/1.73 m²
STANDARD_DEVIATION 32.673 • n=5 Participants
|
88.775 mL/min/1.73 m²
STANDARD_DEVIATION 29.914 • n=4 Participants
|
90.876 mL/min/1.73 m²
STANDARD_DEVIATION 30.387 • 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 who had a baseline (or screening) proteinuria (spot urine could be used if a patient did not have 24 h urine collections) and a baseline or screening estimated glomerular filtration rate (eGFR) value.
Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day at Week 52 and either estimated glomerular filtration rate (eGFR) within normal range at Week 52 or decrease in eGFR \< 20% from baseline at Week 52 if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min). CRR at Week 52 (derived using UP from the 24 h urine collections) was analyzed using a logistic regression model. Factors in the model included treatment and the covariates race (Asian/Non-Asian) and proteinuria at screening (UP/urine creatinine (UC) \<3 or \>=3 g/day). Pairwise comparisons of the modelled proportions of patients with CRR at each dose level to placebo were performed.
Outcome measures
| Measure |
120 mg BI 655064
n=21 Participants
Participants in dose group 1 received two subcutaneous injections per week, one of 120 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
180 mg BI 655064
n=20 Participants
Participants in dose group 2 received two subcutaneous injections per week, one of 180 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 180 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
240 mg BI 655064
n=40 Participants
Participants in dose group 3 received two subcutaneous injections per week of 120 milligrams (mg) of BI 655064 (240 mg in total) on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064, up to 52 weeks.
|
Placebo
n=40 Participants
Participants in the placebo group received two subcutaneous injections per week of placebo on the same day for 3 weeks followed by one subcutaneous injection per week of placebo, up to 52 weeks.
|
|---|---|---|---|---|
|
Percentage of Patients With Complete Renal Response (CRR) at Week 52
|
38.32 Percentage of Participants
|
44.95 Percentage of Participants
|
44.56 Percentage of Participants
|
48.33 Percentage of Participants
|
SECONDARY outcome
Timeframe: At week 26.Population: Intent to treat (ITT) set: This patient set included all patients from the treated set who had a baseline (or screening) proteinuria (spot urine could be used if a patient did not have 24 h urine collections) and a baseline or screening estimated glomerular filtration rate (eGFR) value.
Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day at Week 26 and either estimated glomerular filtration rate (eGFR) within normal range at Week 26 or decrease in eGFR \< 20% from baseline at Week 26 if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min).
Outcome measures
| Measure |
120 mg BI 655064
n=21 Participants
Participants in dose group 1 received two subcutaneous injections per week, one of 120 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
180 mg BI 655064
n=20 Participants
Participants in dose group 2 received two subcutaneous injections per week, one of 180 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 180 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
240 mg BI 655064
n=40 Participants
Participants in dose group 3 received two subcutaneous injections per week of 120 milligrams (mg) of BI 655064 (240 mg in total) on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064, up to 52 weeks.
|
Placebo
n=40 Participants
Participants in the placebo group received two subcutaneous injections per week of placebo on the same day for 3 weeks followed by one subcutaneous injection per week of placebo, up to 52 weeks.
|
|---|---|---|---|---|
|
Percentage of Patients With Complete Renal Response (CRR) at Week 26
|
28.6 Percentage of Participants
|
50.0 Percentage of Participants
|
35.0 Percentage of Participants
|
37.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: At week 26.Population: Intent to treat (ITT) set: This patient set included all patients from the treated set who had a baseline (or screening) proteinuria (spot urine could be used if a patient did not have 24 h urine collections) and a baseline or screening estimated glomerular filtration rate (eGFR) value.
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
| Measure |
120 mg BI 655064
n=21 Participants
Participants in dose group 1 received two subcutaneous injections per week, one of 120 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
180 mg BI 655064
n=20 Participants
Participants in dose group 2 received two subcutaneous injections per week, one of 180 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 180 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
240 mg BI 655064
n=40 Participants
Participants in dose group 3 received two subcutaneous injections per week of 120 milligrams (mg) of BI 655064 (240 mg in total) on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064, up to 52 weeks.
|
Placebo
n=40 Participants
Participants in the placebo group received two subcutaneous injections per week of placebo on the same day for 3 weeks followed by one subcutaneous injection per week of placebo, up to 52 weeks.
|
|---|---|---|---|---|
|
Percentage of Patients With Partial Renal Response (PRR) at Week 26
|
42.9 Percentage of Participants
|
75.0 Percentage of Participants
|
62.5 Percentage of Participants
|
62.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: At week 52.Population: Intent to treat (ITT) set: This patient set included all patients from the treated set who had a baseline (or screening) proteinuria (spot urine could be used if a patient did not have 24 h urine collections) and a baseline or screening estimated glomerular filtration rate (eGFR) value.
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
| Measure |
120 mg BI 655064
n=21 Participants
Participants in dose group 1 received two subcutaneous injections per week, one of 120 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
180 mg BI 655064
n=20 Participants
Participants in dose group 2 received two subcutaneous injections per week, one of 180 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 180 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
240 mg BI 655064
n=40 Participants
Participants in dose group 3 received two subcutaneous injections per week of 120 milligrams (mg) of BI 655064 (240 mg in total) on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064, up to 52 weeks.
|
Placebo
n=40 Participants
Participants in the placebo group received two subcutaneous injections per week of placebo on the same day for 3 weeks followed by one subcutaneous injection per week of placebo, up to 52 weeks.
|
|---|---|---|---|---|
|
Percentage of Patients With Partial Renal Response (PRR) at Week 52
|
33.3 Percentage of Participants
|
65.0 Percentage of Participants
|
55.0 Percentage of Participants
|
60.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: At week 26.Population: Intent to treat (ITT) set: This patient set included all patients from the treated set who had a baseline (or screening) proteinuria (spot urine could be used if a patient did not have 24 h urine collections) and a baseline or screening estimated glomerular filtration rate (eGFR) value.
Major renal response was defined as follows depending on proteinuria at baseline: * If baseline proteinuria was \<3 g/day and patient had complete renal response (CRR) * If baseline proteinuria was \>= 3 g/day and proteinuria \< 1 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \<20% from baseline at Week 26 if eGFR was below normal range (below lower limit of normal (LLN), where LLN = 90 mL/min)
Outcome measures
| Measure |
120 mg BI 655064
n=21 Participants
Participants in dose group 1 received two subcutaneous injections per week, one of 120 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
180 mg BI 655064
n=20 Participants
Participants in dose group 2 received two subcutaneous injections per week, one of 180 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 180 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
240 mg BI 655064
n=40 Participants
Participants in dose group 3 received two subcutaneous injections per week of 120 milligrams (mg) of BI 655064 (240 mg in total) on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064, up to 52 weeks.
|
Placebo
n=40 Participants
Participants in the placebo group received two subcutaneous injections per week of placebo on the same day for 3 weeks followed by one subcutaneous injection per week of placebo, up to 52 weeks.
|
|---|---|---|---|---|
|
Percentage of Patients With Major Renal Response (MRR) at Week 26
|
28.6 Percentage of Participants
|
55.0 Percentage of Participants
|
37.5 Percentage of Participants
|
50.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: At week 52.Population: Intent to treat (ITT) set: This patient set included all patients from the treated set who had a baseline (or screening) proteinuria (spot urine could be used if a patient did not have 24 h urine collections) and a baseline or screening estimated glomerular filtration rate (eGFR) value.
Major renal response was defined as follows depending on proteinuria at baseline: * If baseline proteinuria was \<3 g/day and patient had complete renal response (CRR) * If baseline proteinuria was \>= 3 g/day and proteinuria \< 1 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \<20% from baseline at Week 52 if eGFR was below normal range (below lower limit of normal (LLN), where LLN = 90 mL/min)
Outcome measures
| Measure |
120 mg BI 655064
n=21 Participants
Participants in dose group 1 received two subcutaneous injections per week, one of 120 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
180 mg BI 655064
n=20 Participants
Participants in dose group 2 received two subcutaneous injections per week, one of 180 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 180 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
240 mg BI 655064
n=40 Participants
Participants in dose group 3 received two subcutaneous injections per week of 120 milligrams (mg) of BI 655064 (240 mg in total) on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064, up to 52 weeks.
|
Placebo
n=40 Participants
Participants in the placebo group received two subcutaneous injections per week of placebo on the same day for 3 weeks followed by one subcutaneous injection per week of placebo, up to 52 weeks.
|
|---|---|---|---|---|
|
Percentage of Patients With Major Renal Response (MRR) at Week 52
|
42.9 Percentage of Participants
|
55.0 Percentage of Participants
|
52.5 Percentage of Participants
|
52.5 Percentage of Participants
|
Adverse Events
120 mg BI 655064
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
180 mg BI 655064
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
240 mg BI 655064
Serious events: 10 serious events
Other events: 34 other events
Deaths: 1 deaths
Placebo
Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
120 mg BI 655064
n=21 participants at risk
Participants in dose group 1 received two subcutaneous injections per week, one of 120 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
180 mg BI 655064
n=20 participants at risk
Participants in dose group 2 received two subcutaneous injections per week, one of 180 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 180 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
240 mg BI 655064
n=40 participants at risk
Participants in dose group 3 received two subcutaneous injections per week of 120 milligrams (mg) of BI 655064 (240 mg in total) on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064, up to 52 weeks.
|
Placebo
n=40 participants at risk
Participants in the placebo group received two subcutaneous injections per week of placebo on the same day for 3 weeks followed by one subcutaneous injection per week of placebo, up to 52 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
10.0%
2/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Chorioretinopathy
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Genital herpes simplex
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Herpes zoster
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Meningitis cryptococcal
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Septic shock
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
2/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Renal and urinary disorders
Lupus nephritis
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
Other adverse events
| Measure |
120 mg BI 655064
n=21 participants at risk
Participants in dose group 1 received two subcutaneous injections per week, one of 120 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
180 mg BI 655064
n=20 participants at risk
Participants in dose group 2 received two subcutaneous injections per week, one of 180 milligrams (mg) of BI 655064 and one of matching placebo on the same day for 3 weeks followed by one subcutaneous injection per week of 180 mg of BI 655064 alternating with placebo, up to 52 weeks.
|
240 mg BI 655064
n=40 participants at risk
Participants in dose group 3 received two subcutaneous injections per week of 120 milligrams (mg) of BI 655064 (240 mg in total) on the same day for 3 weeks followed by one subcutaneous injection per week of 120 mg of BI 655064, up to 52 weeks.
|
Placebo
n=40 participants at risk
Participants in the placebo group received two subcutaneous injections per week of placebo on the same day for 3 weeks followed by one subcutaneous injection per week of placebo, up to 52 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
3/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
10.0%
4/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
5/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
15.0%
6/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Endocrine disorders
Cushingoid
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
15.0%
3/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
2/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
2/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Vision blurred
|
9.5%
2/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.8%
5/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
15.0%
3/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
22.5%
9/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
15.0%
6/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
2/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Asthenia
|
9.5%
2/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Fatigue
|
9.5%
2/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Injection site pain
|
9.5%
2/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Oedema peripheral
|
14.3%
3/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
2/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Pyrexia
|
14.3%
3/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
2/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
2/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
2/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
10.0%
4/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
2/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
10.0%
4/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
17.5%
7/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Oral candidiasis
|
9.5%
2/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
23.8%
5/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
30.0%
6/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
17.5%
7/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
20.0%
8/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
10.0%
2/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
10.0%
4/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
15.0%
6/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Investigations
Weight increased
|
9.5%
2/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
10.0%
2/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
5/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
2/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
9.5%
2/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
2/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
5/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
3/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
10.0%
4/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
15.0%
6/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
10.0%
4/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
10.0%
4/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
10.0%
2/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Headache
|
14.3%
3/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
15.0%
6/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
5/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Psychiatric disorders
Insomnia
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
10.0%
2/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
5/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
15.0%
3/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
22.5%
9/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
17.5%
7/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
10.0%
4/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.5%
2/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
15.0%
6/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
2/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
1/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
5.0%
2/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
7.5%
3/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/21 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
10.0%
2/20 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
2.5%
1/40 • From the first does of study medication until end of the 52-week treatment + 8 weeks of follow-up, up to 60 weeks.
Treated set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
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