Trial Outcomes & Findings for A Study of Verinurad and Allopurinol in Patients With Chronic Kidney Disease and Hyperuricaemia (NCT NCT03990363)
NCT ID: NCT03990363
Last Updated: 2023-03-02
Results Overview
Analyses of change from baseline in uACR at 6 months (Visit 8) focused on: * High dose vs Placebo * High dose and Inter. dose combined vs Allopurinol alone * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo For High dose and Inter. dose combined the 2 categories merged forming 1 new temporary category.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
861 participants
Primary outcome timeframe
Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8)
Results posted on
2023-03-02
Participant Flow
Participants were enrolled if: * serum uric acid was greated than or equal to 6 mg/dL and * estimated glomerular filtration rate was greated than or equal to 25 mL/min/1.73 m2 and * urinary albumin to creatinine ratio was greated than or equal to 30 mg/g and less than or equal to 5000 mg/g
Participant milestones
| Measure |
High Dose
Verinurad 12 mg plus allopurinol 300 mg
|
Intermediate Dose
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg)
|
Low Dose
Verinurad 3 mg plus allopurinol 300 mg.
As per Protocol Version 5.0, participants from 3 mg dose were switched to 24 mg at Visit 9.
|
Allopurinol
Allopurinol alone (Allopurinol): 300 mg
|
Placebo
Placebo only
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
172
|
172
|
173
|
171
|
173
|
|
Overall Study
Switch Dose
|
0
|
0
|
37
|
0
|
0
|
|
Overall Study
COMPLETED
|
137
|
143
|
131
|
145
|
147
|
|
Overall Study
NOT COMPLETED
|
35
|
29
|
42
|
26
|
26
|
Reasons for withdrawal
| Measure |
High Dose
Verinurad 12 mg plus allopurinol 300 mg
|
Intermediate Dose
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg)
|
Low Dose
Verinurad 3 mg plus allopurinol 300 mg.
As per Protocol Version 5.0, participants from 3 mg dose were switched to 24 mg at Visit 9.
|
Allopurinol
Allopurinol alone (Allopurinol): 300 mg
|
Placebo
Placebo only
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
9
|
18
|
11
|
9
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
3
|
2
|
2
|
0
|
|
Overall Study
Death
|
14
|
8
|
14
|
10
|
11
|
|
Overall Study
Failure to meet randomization criteria
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
2
|
|
Overall Study
Non-compliance with study drug
|
2
|
1
|
2
|
0
|
0
|
|
Overall Study
Study terminated by sponsor
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Site terminated by sponsor
|
2
|
1
|
2
|
0
|
2
|
|
Overall Study
Not categorized
|
5
|
5
|
3
|
2
|
2
|
Baseline Characteristics
A Study of Verinurad and Allopurinol in Patients With Chronic Kidney Disease and Hyperuricaemia
Baseline characteristics by cohort
| Measure |
High Dose
n=172 Participants
Verinurad 12 mg plus allopurinol 300 mg
|
Inter. Dose
n=172 Participants
Verinurad 7.5 mg plus allopurinol 300 mg
|
Low Dose
n=173 Participants
Verinurad 3 mg plus allopurinol 300 mg.
As per Protocol Version 5.0, participants from 3 mg dose were switched to 24 mg at Visit 9.
|
Allopurinol
n=171 Participants
Allopurinol alone (Allopurinol): 300 mg
|
Placebo
n=173 Participants
Placebo only
|
Total
n=861 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.3 Years
STANDARD_DEVIATION 10.0 • n=99 Participants
|
64.9 Years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
65.3 Years
STANDARD_DEVIATION 11.2 • n=206 Participants
|
65.1 Years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
65.8 Years
STANDARD_DEVIATION 10.4 • n=31 Participants
|
65.3 Years
STANDARD_DEVIATION 10.8 • n=30 Participants
|
|
Age, Customized
>=65
|
100 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
95 Participants
n=7 Participants
|
107 Participants
n=31 Participants
|
509 Participants
n=30 Participants
|
|
Age, Customized
<65
|
72 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
76 Participants
n=7 Participants
|
66 Participants
n=31 Participants
|
352 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
50 Participants
n=31 Participants
|
284 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=99 Participants
|
119 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
116 Participants
n=7 Participants
|
123 Participants
n=31 Participants
|
577 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
41 Participants
n=31 Participants
|
205 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
130 Participants
n=99 Participants
|
127 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
131 Participants
n=7 Participants
|
132 Participants
n=31 Participants
|
656 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
29 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
20 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
116 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
126 Participants
n=206 Participants
|
118 Participants
n=7 Participants
|
131 Participants
n=31 Participants
|
622 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
72 Participants
n=30 Participants
|
|
Region of Enrollment
Czech Republic
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
28 Participants
n=30 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
|
Region of Enrollment
Hungary
|
22 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
107 Participants
n=30 Participants
|
|
Region of Enrollment
Israel
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
79 Participants
n=30 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
|
Region of Enrollment
Mexico
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
36 Participants
n=30 Participants
|
|
Region of Enrollment
Poland
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
|
Region of Enrollment
Romania
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
22 Participants
n=30 Participants
|
|
Region of Enrollment
Slovakia
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
38 Participants
n=30 Participants
|
|
Region of Enrollment
South Africa
|
23 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
111 Participants
n=30 Participants
|
|
Region of Enrollment
Spain
|
17 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
76 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
70 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
71 Participants
n=7 Participants
|
61 Participants
n=31 Participants
|
337 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8)Population: Full analysis set (evaluable participant included only) In the primary endpoint the arms are presented as comparisons of treatment groups with either placebo or allopurinol alone. Geometric mean ratio is presented between arms as a pre-specified analysis.
Analyses of change from baseline in uACR at 6 months (Visit 8) focused on: * High dose vs Placebo * High dose and Inter. dose combined vs Allopurinol alone * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo For High dose and Inter. dose combined the 2 categories merged forming 1 new temporary category.
Outcome measures
| Measure |
High Dose Versus Placebo
n=284 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus placebo
|
High Dose and Intermediate Dose Combined Versus Allopurinol
n=434 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) and intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) combined versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Placebo
n=297 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus placebo
|
Low Dose Versus Placebo
n=290 Participants
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus placebo
|
High Dose Versus Allopurinol
n=283 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Allopurinol
n=296 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Low Dose Versus Allopurinol
n=289 Participants
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300mg)
|
Allopurinol Versus Placebo
n=291 Participants
Allopurinol (allopurinol 300mg) versus placebo
|
|---|---|---|---|---|---|---|---|---|
|
Urinary Albumin to Creatinine Ratio (uACR) (mg/g) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM)
|
0.8300 mg/g
Interval 0.681 to 1.012
|
1.043 mg/g
Interval 0.8793 to 1.237
|
0.8369 mg/g
Interval 0.6887 to 1.017
|
0.8499 mg/g
Interval 0.6984 to 1.034
|
1.037 mg/g
Interval 0.8506 to 1.265
|
1.046 mg/g
Interval 0.8603 to 1.272
|
1.062 mg/g
Interval 0.8725 to 1.293
|
0.8001 mg/g
Interval 0.6573 to 0.9739
|
SECONDARY outcome
Timeframe: Baseline to 12 months (Visit 10); analysis at 12 months (Visit 10)Population: Full analysis set (evaluable participant included only) In this secondary endpoint the arm presented provides a comparison between the Switch Dose group and double-capsule placebo at Visit 10. This is a pre-specified analysis between the Switch Dose group and double-capsule placebo at Visit 10. Geometric mean ratio is presented between arms as a pre-specified analysis.
Change from baseline in uACR at 12 months (Visit 10) for comparison of Switch dose protocol version 5.0 (PA5) versus double-capsule Placebo. The statistical model applied was an MMRM, which was basically the same as the one applied in the primary analysis but adjusted for a 12 month horizon and adapted to the double-capsule regimen from Visit 9 on.
Outcome measures
| Measure |
High Dose Versus Placebo
n=78 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus placebo
|
High Dose and Intermediate Dose Combined Versus Allopurinol
High dose (verinurad 12 mg plus allopurinol 300 mg) and intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) combined versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Placebo
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus placebo
|
Low Dose Versus Placebo
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus placebo
|
High Dose Versus Allopurinol
High dose (verinurad 12 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Allopurinol
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Low Dose Versus Allopurinol
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300mg)
|
Allopurinol Versus Placebo
Allopurinol (allopurinol 300mg) versus placebo
|
|---|---|---|---|---|---|---|---|---|
|
Urinary Albumin to Creatinine Ratio (uACR) (mg/g) Change From Baseline at 12 Months (Visit 10), Repeated Measures Mixed Model (MMRM)
|
1.016 mg/g
Interval 0.7437 to 1.388
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8)Population: Full analysis set (evaluable participant included only) In this secondary endpoint the arms are presented as comparisons of treatment groups with either placebo or allopurinol alone. Geometric mean ratio is presented between arms as a pre-specified analysis.
Change from baseline in sUA at 6 months (Visit 8), there were 7 comparisons requested for each endpoint, namely: * High dose vs Placebo * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo.
Outcome measures
| Measure |
High Dose Versus Placebo
n=285 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus placebo
|
High Dose and Intermediate Dose Combined Versus Allopurinol
n=297 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) and intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) combined versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Placebo
n=291 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus placebo
|
Low Dose Versus Placebo
n=280 Participants
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus placebo
|
High Dose Versus Allopurinol
n=292 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Allopurinol
n=286 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Low Dose Versus Allopurinol
n=289 Participants
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300mg)
|
Allopurinol Versus Placebo
Allopurinol (allopurinol 300mg) versus placebo
|
|---|---|---|---|---|---|---|---|---|
|
Serum Uric Acid (sUA) (mg/dL) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM)
|
0.5098 mg/dL
Interval 0.4701 to 0.5528
|
0.5810 mg/dL
Interval 0.5362 to 0.6295
|
0.6096 mg/dL
Interval 0.5623 to 0.6609
|
0.8184 mg/dL
Interval 0.7544 to 0.8878
|
0.9327 mg/dL
Interval 0.8604 to 1.011
|
0.9786 mg/dL
Interval 0.9024 to 1.061
|
0.6229 mg/dL
Interval 0.5744 to 0.6755
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months (Visit 10); analysis at 12 months (Visit 10)Population: Full analysis set (evaluable participant included only) In this secondary endpoint the arm presented provides a comparison between the Switch Dose group and double-capsule placebo at Visit 10. This is a pre-specified analysis between the Switch Dose group and double-capsule placebo at Visit 10. Geometric mean ratio is presented between arms as a pre-specified analysis.
Change from baseline in sUA at 12 months (Visit 10) for comparison of Switch dose protocol version 5.0 (PA5) versus double-capsule Placebo.
Outcome measures
| Measure |
High Dose Versus Placebo
n=74 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus placebo
|
High Dose and Intermediate Dose Combined Versus Allopurinol
High dose (verinurad 12 mg plus allopurinol 300 mg) and intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) combined versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Placebo
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus placebo
|
Low Dose Versus Placebo
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus placebo
|
High Dose Versus Allopurinol
High dose (verinurad 12 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Allopurinol
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Low Dose Versus Allopurinol
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300mg)
|
Allopurinol Versus Placebo
Allopurinol (allopurinol 300mg) versus placebo
|
|---|---|---|---|---|---|---|---|---|
|
Serum Uric Acid (sUA) Change From Baseline at 12 Months (Visit 10), Repeated Measures Mixed Model (MMRM)
|
0.5540 mg/dL
Interval 0.4825 to 0.6362
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8)Population: Full analysis set (evaluable participant included only) In this secondary endpoint the arms are presented as comparisons of treatment groups with either placebo or allopurinol alone. Geometric mean ratio is presented between arms as a pre-specified analysis.
Change from baseline in eGFR at 6 months (Visit 8), there were 7 comparisons requested for this endpoint, namely: * High dose vs Placebo * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo.
Outcome measures
| Measure |
High Dose Versus Placebo
n=285 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus placebo
|
High Dose and Intermediate Dose Combined Versus Allopurinol
n=297 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) and intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) combined versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Placebo
n=291 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus placebo
|
Low Dose Versus Placebo
n=280 Participants
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus placebo
|
High Dose Versus Allopurinol
n=292 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Allopurinol
n=286 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Low Dose Versus Allopurinol
n=289 Participants
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300mg)
|
Allopurinol Versus Placebo
Allopurinol (allopurinol 300mg) versus placebo
|
|---|---|---|---|---|---|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR) (mL/Min/1.73 m²) Change From Baseline at 6 Months (V8), Repeated Measures Mixed Model (MMRM)
|
1.009 mL/min/1.73 m²
Interval 0.9647 to 1.056
|
0.9730 mL/min/1.73 m²
Interval 0.9307 to 1.017
|
1.010 mL/min/1.73 m²
Interval 0.966 to 1.056
|
1.023 mL/min/1.73 m²
Interval 0.9773 to 1.07
|
0.9859 mL/min/1.73 m²
Interval 0.9429 to 1.031
|
1.024 mL/min/1.73 m²
Interval 0.9786 to 1.071
|
0.9868 mL/min/1.73 m²
Interval 0.9436 to 1.032
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 12 months (Visit 10)Population: Full analysis set (evaluable participant included only)
Change from baseline in eGFR at 12 months (Visit 10) for the following treatments: * High Dose * Inter. Dose * Low Dose (a) * Switch Dose protocol version 5.0 (PA5) (b) * Allopurinol * Placebo 1. Subjects that switched from Verinurad 3 mg to Verinurad 24 mg at Visit 9 are not included in this group for Visit 10. 2. Contains all subjects randomized to the low dose group that later switched to Verinurad 24 mg plus Allopurinol 300 mg.
Outcome measures
| Measure |
High Dose Versus Placebo
n=124 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus placebo
|
High Dose and Intermediate Dose Combined Versus Allopurinol
n=137 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) and intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) combined versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Placebo
n=99 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus placebo
|
Low Dose Versus Placebo
n=34 Participants
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus placebo
|
High Dose Versus Allopurinol
n=131 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Allopurinol
n=138 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Low Dose Versus Allopurinol
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300mg)
|
Allopurinol Versus Placebo
Allopurinol (allopurinol 300mg) versus placebo
|
|---|---|---|---|---|---|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR) (mL/Min/1.73 m²) Change From Baseline at 12 Months (Visit 10)
|
0.9809 mL/min/1.73 m²
Geometric Coefficient of Variation 20.09
|
0.9454 mL/min/1.73 m²
Geometric Coefficient of Variation 21.24
|
0.9613 mL/min/1.73 m²
Geometric Coefficient of Variation 17.59
|
1.101 mL/min/1.73 m²
Geometric Coefficient of Variation 27.23
|
0.9593 mL/min/1.73 m²
Geometric Coefficient of Variation 23.36
|
0.9469 mL/min/1.73 m²
Geometric Coefficient of Variation 23.33
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8)Population: Full analysis set (evaluable participant included only) In this secondary endpoint the arms are presented as comparisons of treatment groups with either placebo or allopurinol alone. Geometric mean ratio is presented between arms as a pre-specified analysis.
Change from baseline in S-creatinine at 6 months (Visit 8), there were 7 comparisons requested for this endpoint, namely: * High dose vs Placebo * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo.
Outcome measures
| Measure |
High Dose Versus Placebo
n=285 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus placebo
|
High Dose and Intermediate Dose Combined Versus Allopurinol
n=297 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) and intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) combined versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Placebo
n=291 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus placebo
|
Low Dose Versus Placebo
n=280 Participants
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus placebo
|
High Dose Versus Allopurinol
n=292 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Allopurinol
n=286 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Low Dose Versus Allopurinol
n=289 Participants
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300mg)
|
Allopurinol Versus Placebo
Allopurinol (allopurinol 300mg) versus placebo
|
|---|---|---|---|---|---|---|---|---|
|
S-creatinine (mg/dL) Change From Baseline at 6 Months (V8), Repeated Measures Mixed Model (MMRM)
|
0.9888 Geometric Mean Ratio
Interval 0.9523 to 1.027
|
1.023 Geometric Mean Ratio
Interval 0.9857 to 1.062
|
0.9901 Geometric Mean Ratio
Interval 0.9538 to 1.028
|
0.9801 Geometric Mean Ratio
Interval 0.9437 to 1.018
|
1.014 Geometric Mean Ratio
Interval 0.977 to 1.053
|
0.9814 Geometric Mean Ratio
Interval 0.9452 to 1.019
|
1.009 Geometric Mean Ratio
Interval 0.9718 to 1.047
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 12 months (Visit 10)Population: Full analysis set (evaluable participant included only)
Change from baseline in S-creatinine at 12 months (Visit 10) for the following treatments: * High Dose * Inter. Dose * Low Dose (a) * Switch Dose protocol version 5.0 (PA5) (b) * Allopurinol * Placebo 1. Subjects that switched from Verinurad 3 mg to Verinurad 24 mg at Visit 9 are not included in this group for Visit 10. 2. Contains all subjects randomized to the low dose group that later switched to Verinurad 24 mg plus Allopurinol 300 mg.
Outcome measures
| Measure |
High Dose Versus Placebo
n=124 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus placebo
|
High Dose and Intermediate Dose Combined Versus Allopurinol
n=137 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) and intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) combined versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Placebo
n=99 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus placebo
|
Low Dose Versus Placebo
n=34 Participants
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus placebo
|
High Dose Versus Allopurinol
n=131 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Allopurinol
n=138 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Low Dose Versus Allopurinol
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300mg)
|
Allopurinol Versus Placebo
Allopurinol (allopurinol 300mg) versus placebo
|
|---|---|---|---|---|---|---|---|---|
|
S-creatinine (mg/dL) Change From Baseline at 12 Months (Visit 10)
|
1.011 mg/dL
Geometric Coefficient of Variation 18.57
|
1.038 mg/dL
Geometric Coefficient of Variation 18.37
|
1.026 mg/dL
Geometric Coefficient of Variation 17.15
|
0.9078 mg/dL
Geometric Coefficient of Variation 17.66
|
1.028 mg/dL
Geometric Coefficient of Variation 24.44
|
1.043 mg/dL
Geometric Coefficient of Variation 20.91
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8)Population: Full analysis set (evaluable participant included only) In this secondary endpoint the arms are presented as comparisons of treatment groups with either placebo or allopurinol alone. Geometric mean ratio is presented between arms as a pre-specified analysis.
Change from baseline in P-cystatin C at 6 months (Visit 8), there were 7 comparisons requested for this endpoint, namely: * High dose vs Placebo * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo.
Outcome measures
| Measure |
High Dose Versus Placebo
n=288 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus placebo
|
High Dose and Intermediate Dose Combined Versus Allopurinol
n=299 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) and intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) combined versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Placebo
n=294 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus placebo
|
Low Dose Versus Placebo
n=281 Participants
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus placebo
|
High Dose Versus Allopurinol
n=292 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Allopurinol
n=287 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Low Dose Versus Allopurinol
n=291 Participants
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300mg)
|
Allopurinol Versus Placebo
Allopurinol (allopurinol 300mg) versus placebo
|
|---|---|---|---|---|---|---|---|---|
|
P-cystatin C (mg/L) Change From Baseline at 6 Months (V8), Repeated Measures Mixed Model (MMRM)
|
1.009 Geometric Mean Ratio
Interval 0.9758 to 1.042
|
1.038 Geometric Mean Ratio
Interval 1.005 to 1.073
|
1.018 Geometric Mean Ratio
Interval 0.9856 to 1.052
|
0.9849 Geometric Mean Ratio
Interval 0.9528 to 1.018
|
1.014 Geometric Mean Ratio
Interval 0.9813 to 1.048
|
0.9946 Geometric Mean Ratio
Interval 0.9623 to 1.028
|
1.024 Geometric Mean Ratio
Interval 0.9908 to 1.058
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 12 months (Visit 10)Population: Full analysis set (evaluable participant included only)
Change from baseline in S-creatinine at 12 months (Visit 10) for the following treatments: * High Dose * Inter. Dose * Low Dose (a) * Switch Dose protocol version 5.0 (PA5) (b) * Allopurinol * Placebo 1. Subjects that switched from Verinurad 3 mg to Verinurad 24 mg at Visit 9 are not included in this group for Visit 10. 2. Contains all subjects randomized to the low dose group that later switched to Verinurad 24 mg plus Allopurinol 300 mg.
Outcome measures
| Measure |
High Dose Versus Placebo
n=124 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus placebo
|
High Dose and Intermediate Dose Combined Versus Allopurinol
n=141 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) and intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) combined versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Placebo
n=99 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus placebo
|
Low Dose Versus Placebo
n=34 Participants
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus placebo
|
High Dose Versus Allopurinol
n=131 Participants
High dose (verinurad 12 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Intermediate Dose Versus Allopurinol
n=138 Participants
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300 mg)
|
Low Dose Versus Allopurinol
Low dose (verinurad 3 mg plus allopurinol 300 mg) versus allopurinol (allopurinol 300mg)
|
Allopurinol Versus Placebo
Allopurinol (allopurinol 300mg) versus placebo
|
|---|---|---|---|---|---|---|---|---|
|
P-cystatin C (mg/L) Change From Baseline at 12 Months (Visit 10)
|
1.070 mg/L
Geometric Coefficient of Variation 17.98
|
1.079 mg/L
Geometric Coefficient of Variation 15.63
|
1.065 mg/L
Geometric Coefficient of Variation 16.51
|
1.018 mg/L
Geometric Coefficient of Variation 13.68
|
1.083 mg/L
Geometric Coefficient of Variation 23.13
|
1.048 mg/L
Geometric Coefficient of Variation 14.89
|
—
|
—
|
Adverse Events
High Dose
Serious events: 36 serious events
Other events: 32 other events
Deaths: 14 deaths
Intermediate Dose
Serious events: 39 serious events
Other events: 32 other events
Deaths: 8 deaths
Low Dose
Serious events: 40 serious events
Other events: 28 other events
Deaths: 13 deaths
Switch Dose
Serious events: 4 serious events
Other events: 1 other events
Deaths: 1 deaths
Allopurinol
Serious events: 42 serious events
Other events: 39 other events
Deaths: 10 deaths
Placebo
Serious events: 35 serious events
Other events: 49 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
High Dose
n=172 participants at risk
Verinurad 12 mg plus allopurinol 300 mg
|
Intermediate Dose
n=172 participants at risk
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg)
|
Low Dose
n=172 participants at risk
Verinurad 3 mg plus allopurinol 300 mg.
As per Protocol Version 5.0, participants from 3 mg dose were switched to 24 mg at Visit 9.
|
Switch Dose
n=37 participants at risk
As per Protocol Version 5.0, participants from 3 mg dose (ie, Low Dose group) were switched to 24 mg at Visit 9. Participants received Verinurad 24 mg and Allopurinol 300 mg.
|
Allopurinol
n=171 participants at risk
Allopurinol alone (Allopurinol): 300 mg
|
Placebo
n=173 participants at risk
Placebo only
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Localised infection
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Pneumonia
|
1.7%
3/172 • Number of events 3 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.3%
4/172 • Number of events 4 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Pyelonephritis acute
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Sepsis
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Septic shock
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Urinary tract infection
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/171 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Injury, poisoning and procedural complications
Fall
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Investigations
Sars-cov-2 test positive
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/171 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/171 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to the mediastinum
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Cardiac failure
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.7%
3/173 • Number of events 5 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.7%
1/37 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/171 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Migraine
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Psychiatric disorders
Mental status changes
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
3/172 • Number of events 3 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.7%
3/172 • Number of events 3 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Renal and urinary disorders
End stage renal disease
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.3%
4/171 • Number of events 6 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Vascular disorders
Haematoma
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Vascular disorders
Hypertension
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Vascular disorders
Shock
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Paroxysmal atrioventricular block
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Eye disorders
Amaurosis fugax
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Eye disorders
Cataract
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
General disorders
Sudden death
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
General disorders
Cardiac death
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
General disorders
Chest pain
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/171 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
General disorders
Death
|
1.7%
3/172 • Number of events 3 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
General disorders
Oedema peripheral
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
General disorders
Vascular stent thrombosis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Hepatobiliary disorders
Cholangitis
|
0.58%
1/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/171 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Immune system disorders
Sarcoidosis
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Atypical pneumonia
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Covid-19
|
1.7%
3/172 • Number of events 3 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.7%
3/172 • Number of events 3 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.3%
4/172 • Number of events 4 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
3.5%
6/171 • Number of events 6 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.3%
4/173 • Number of events 4 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Covid-19 pneumonia
|
2.3%
4/172 • Number of events 4 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.7%
3/172 • Number of events 3 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.9%
5/172 • Number of events 5 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.8%
3/171 • Number of events 3 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.7%
3/173 • Number of events 3 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Cellulitis
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Complicated appendicitis
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/171 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/171 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Infections and infestations
Gastroenteritis
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/173 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
Other adverse events
| Measure |
High Dose
n=172 participants at risk
Verinurad 12 mg plus allopurinol 300 mg
|
Intermediate Dose
n=172 participants at risk
Intermediate dose (verinurad 7.5 mg plus allopurinol 300 mg)
|
Low Dose
n=172 participants at risk
Verinurad 3 mg plus allopurinol 300 mg.
As per Protocol Version 5.0, participants from 3 mg dose were switched to 24 mg at Visit 9.
|
Switch Dose
n=37 participants at risk
As per Protocol Version 5.0, participants from 3 mg dose (ie, Low Dose group) were switched to 24 mg at Visit 9. Participants received Verinurad 24 mg and Allopurinol 300 mg.
|
Allopurinol
n=171 participants at risk
Allopurinol alone (Allopurinol): 300 mg
|
Placebo
n=173 participants at risk
Placebo only
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
4.7%
8/172 • Number of events 9 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.3%
4/172 • Number of events 4 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
3.5%
6/172 • Number of events 6 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.8%
3/171 • Number of events 4 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
6.4%
11/173 • Number of events 13 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Vascular disorders
Hypertension
|
3.5%
6/172 • Number of events 6 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
5.2%
9/172 • Number of events 12 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.9%
5/172 • Number of events 7 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
7.0%
12/171 • Number of events 13 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
4.0%
7/173 • Number of events 8 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
7/172 • Number of events 7 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.9%
5/172 • Number of events 5 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
4.7%
8/171 • Number of events 9 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
6.4%
11/173 • Number of events 12 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/172 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.9%
5/172 • Number of events 5 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
5.3%
9/171 • Number of events 10 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.2%
2/173 • Number of events 8 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Metabolism and nutrition disorders
Gout
|
1.7%
3/172 • Number of events 3 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
3.5%
6/172 • Number of events 7 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
5.2%
9/172 • Number of events 9 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.9%
5/171 • Number of events 7 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
7.5%
13/173 • Number of events 19 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.9%
5/172 • Number of events 5 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.3%
4/172 • Number of events 4 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
1.7%
3/172 • Number of events 3 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
0.00%
0/37 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.9%
5/171 • Number of events 5 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
5.8%
10/173 • Number of events 13 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
9/172 • Number of events 10 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.9%
5/172 • Number of events 6 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.3%
4/172 • Number of events 4 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
2.9%
5/171 • Number of events 6 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
6.4%
11/173 • Number of events 11 • Adverse events were collected from Visit 3 (Week 0) until End of Treatment Visit, Visit 10 (Week 60).
From Visit 3 until Visit 10, instances of death, serious adverse events, and non-serious adverse events (with a frequency of \>5%) are presented. The exposure was shorter in the Low Dose and Switch Dose arms, since this is while under 3 mg treatment up to Visit 10 or beyond and while under 24 mg treatment from Visit 9 to Visit 10, respectively. There were 14 subjects that started on Low Dose that died, 1 of these died during the period in which they had changed to the Switch Dose group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place