Trial Outcomes & Findings for Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis (NCT NCT01473524)
NCT ID: NCT01473524
Last Updated: 2021-05-06
Results Overview
Percentage of participants at Month 12 with ALP \< 1.67 x upper limit of normal (ULN) and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
217 participants
Primary outcome timeframe
DB Month 12
Results posted on
2021-05-06
Participant Flow
Recruitment into hospitals and physicians' clinics started January 2012 and completed December 2012.
Screening interim allowed for pre-randomization eligibility assessment of 1 to 8 weeks. A total of 217 participants were randomized into the double-blind phase of the study, however, 216 received treatment with study drug. One randomized participant discontinued prior to receiving any study drug.
Participant milestones
| Measure |
DB OCA 5-10 mg
Obeticholic acid (OCA) 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remaining 6 months of the double-blind (DB) phase.
|
DB OCA 10 mg
OCA 10 mg for 12 months during DB phase.
|
DB Placebo
Matching placebo for 12 months in the DB phase.
|
LTSE OCA (DB OCA 5-10 mg)
Participants previously receiving OCA 5 to 10 mg in the DB phase received OCA in the open-label long-term safety extension (LTSE) phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
LTSE OCA (DB OCA 10 mg)
Participants previously receiving OCA 10 mg in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
LTSE OCA (DB Placebo)
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|---|---|
|
DB Phase
STARTED
|
71
|
73
|
73
|
0
|
0
|
0
|
|
DB Phase
Received at Least 1 Dose of Study Drug
|
70
|
73
|
73
|
0
|
0
|
0
|
|
DB Phase
COMPLETED
|
64
|
64
|
70
|
0
|
0
|
0
|
|
DB Phase
NOT COMPLETED
|
7
|
9
|
3
|
0
|
0
|
0
|
|
LTSE Phase
STARTED
|
0
|
0
|
0
|
63
|
64
|
66
|
|
LTSE Phase
Received at Least 1 Dose of OCA in LTSE
|
0
|
0
|
0
|
63
|
64
|
66
|
|
LTSE Phase
COMPLETED
|
0
|
0
|
0
|
54
|
47
|
45
|
|
LTSE Phase
NOT COMPLETED
|
0
|
0
|
0
|
9
|
17
|
21
|
Reasons for withdrawal
| Measure |
DB OCA 5-10 mg
Obeticholic acid (OCA) 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remaining 6 months of the double-blind (DB) phase.
|
DB OCA 10 mg
OCA 10 mg for 12 months during DB phase.
|
DB Placebo
Matching placebo for 12 months in the DB phase.
|
LTSE OCA (DB OCA 5-10 mg)
Participants previously receiving OCA 5 to 10 mg in the DB phase received OCA in the open-label long-term safety extension (LTSE) phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
LTSE OCA (DB OCA 10 mg)
Participants previously receiving OCA 10 mg in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
LTSE OCA (DB Placebo)
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|---|---|
|
DB Phase
Adverse Event
|
4
|
8
|
2
|
0
|
0
|
0
|
|
DB Phase
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
|
DB Phase
Withdrawal by Subject
|
2
|
1
|
1
|
0
|
0
|
0
|
|
LTSE Phase
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
3
|
6
|
|
LTSE Phase
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
|
LTSE Phase
Adverse Event of Pruritus
|
0
|
0
|
0
|
1
|
5
|
2
|
|
LTSE Phase
Other Clinical/ Laboratory Adverse Event
|
0
|
0
|
0
|
2
|
4
|
6
|
|
LTSE Phase
Lost to Follow-up
|
0
|
0
|
0
|
1
|
3
|
2
|
|
LTSE Phase
Principal Investigator Decision
|
0
|
0
|
0
|
1
|
1
|
3
|
|
LTSE Phase
Liver Transplantation
|
0
|
0
|
0
|
0
|
0
|
1
|
|
LTSE Phase
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
0
|
|
LTSE Phase
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
Baseline characteristics by cohort
| Measure |
DB OCA 5-10 mg
n=70 Participants
OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remaining 6 months of the DB phase.
After completion of the 12-month DB phase participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
DB OCA 10 mg
n=73 Participants
OCA 10 mg 12 months during the DB phase. After completion of the 12-month DB phase participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
DB Placebo
n=73 Participants
Matching placebo for 12 months during the DB phase. After completion of the 12-month DB phase participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
176 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 10.53 • n=99 Participants
|
56.2 years
STANDARD_DEVIATION 11.00 • n=107 Participants
|
55.5 years
STANDARD_DEVIATION 10.03 • n=206 Participants
|
55.8 years
STANDARD_DEVIATION 10.48 • n=7 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
196 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
5 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
67 participants
n=99 Participants
|
70 participants
n=107 Participants
|
66 participants
n=206 Participants
|
203 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
19 participants
n=107 Participants
|
17 participants
n=206 Participants
|
54 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
22 participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
9 participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=99 Participants
|
7 participants
n=107 Participants
|
6 participants
n=206 Participants
|
16 participants
n=7 Participants
|
|
Region of Enrollment
Sweden
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=99 Participants
|
9 participants
n=107 Participants
|
5 participants
n=206 Participants
|
16 participants
n=7 Participants
|
|
Region of Enrollment
Poland
|
4 participants
n=99 Participants
|
6 participants
n=107 Participants
|
4 participants
n=206 Participants
|
14 participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
11 participants
n=99 Participants
|
10 participants
n=107 Participants
|
11 participants
n=206 Participants
|
32 participants
n=7 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
9 participants
n=7 Participants
|
|
Region of Enrollment
France
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=99 Participants
|
11 participants
n=107 Participants
|
9 participants
n=206 Participants
|
28 participants
n=7 Participants
|
|
Alkaline Phosphatase (U/L)
|
325.87 U/L
STANDARD_DEVIATION 116.238 • n=99 Participants
|
316.34 U/L
STANDARD_DEVIATION 103.881 • n=107 Participants
|
327.49 U/L
STANDARD_DEVIATION 115.014 • n=206 Participants
|
323.19 U/L
STANDARD_DEVIATION 111.375 • n=7 Participants
|
|
Total Bilirubin (umol/L)
|
10.192 umol/L
STANDARD_DEVIATION 5.549 • n=99 Participants
|
11.278 umol/L
STANDARD_DEVIATION 6.634 • n=107 Participants
|
11.757 umol/L
STANDARD_DEVIATION 7.227 • n=206 Participants
|
11.088 umol/L
STANDARD_DEVIATION 6.522 • n=7 Participants
|
|
Direct Bilirubin (umol/L)
|
4.398 umol/L
STANDARD_DEVIATION 4.528 • n=99 Participants
|
4.868 umol/L
STANDARD_DEVIATION 4.473 • n=107 Participants
|
5.469 umol/L
STANDARD_DEVIATION 6.214 • n=206 Participants
|
4.919 umol/L
STANDARD_DEVIATION 5.138 • n=7 Participants
|
|
Alanine Aminotransferase (ALT) (U/L)
|
61.56 U/L
STANDARD_DEVIATION 39.037 • n=99 Participants
|
56.31 U/L
STANDARD_DEVIATION 39.741 • n=107 Participants
|
55.99 U/L
STANDARD_DEVIATION 30.312 • n=206 Participants
|
57.9 U/L
STANDARD_DEVIATION 36.498 • n=7 Participants
|
|
Aspartate Aminotransferase (AST) (U/L)
|
52.25 U/L
STANDARD_DEVIATION 25.289 • n=99 Participants
|
50.49 U/L
STANDARD_DEVIATION 31.100 • n=107 Participants
|
48.79 U/L
STANDARD_DEVIATION 22.449 • n=206 Participants
|
50.49 U/L
STANDARD_DEVIATION 26.456 • n=7 Participants
|
|
Gamma-Glutamyltransferase (GGT) (U/L)
|
252.83 U/L
STANDARD_DEVIATION 167.038 • n=99 Participants
|
261.07 U/L
STANDARD_DEVIATION 207.396 • n=107 Participants
|
309.58 U/L
STANDARD_DEVIATION 449.356 • n=206 Participants
|
274.79 U/L
STANDARD_DEVIATION 302.673 • n=7 Participants
|
PRIMARY outcome
Timeframe: DB Month 12Population: Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug.
Percentage of participants at Month 12 with ALP \< 1.67 x upper limit of normal (ULN) and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.
Outcome measures
| Measure |
DB OCA 10 mg
n=73 Participants
OCA 10 mg for 12 months during the DB phase.
|
DB Placebo
n=73 Participants
Matching placebo for 12 months during the DB phase.
|
LTSE OCA (DB Placebo)
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Overall LTSE OCA
After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|
|
DB Phase: Composite Endpoint Alkaline Phosphatase (ALP) And Total Bilirubin, 10 mg OCA Versus Placebo
|
47 percentage of participants
|
10 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (DB Month 12), LTSE Months 24, 36, 48, and 60Population: All participants who received at least 1 dose of OCA in the open-label safety extension phase and had an assessment at the specified timepoint.
Percentage of participants at Months 24, 36, 48, and 60 with ALP \< 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline. DB Month 12 is the baseline for the LTSE phase.
Outcome measures
| Measure |
DB OCA 10 mg
n=63 Participants
OCA 10 mg for 12 months during the DB phase.
|
DB Placebo
n=64 Participants
Matching placebo for 12 months during the DB phase.
|
LTSE OCA (DB Placebo)
n=66 Participants
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Overall LTSE OCA
n=193 Participants
After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|
|
LTSE Phase: Composite Endpoint ALP And Total Bilirubin
Baseline (Double-blind Month 12)
|
51 percentage of participants
|
56 percentage of participants
|
9 percentage of participants
|
38 percentage of participants
|
|
LTSE Phase: Composite Endpoint ALP And Total Bilirubin
LTSE Month 12
|
55 percentage of participants
|
58 percentage of participants
|
41 percentage of participants
|
51 percentage of participants
|
|
LTSE Phase: Composite Endpoint ALP And Total Bilirubin
LTSE Month 24
|
60 percentage of participants
|
61 percentage of participants
|
54 percentage of participants
|
58 percentage of participants
|
|
LTSE Phase: Composite Endpoint ALP And Total Bilirubin
LTSE Month 36
|
48 percentage of participants
|
51 percentage of participants
|
49 percentage of participants
|
49 percentage of participants
|
|
LTSE Phase: Composite Endpoint ALP And Total Bilirubin
LTSE Month 48
|
52 percentage of participants
|
55 percentage of participants
|
60 percentage of participants
|
56 percentage of participants
|
|
LTSE Phase: Composite Endpoint ALP And Total Bilirubin
LTSE Month 60
|
48 percentage of participants
|
52 percentage of participants
|
50 percentage of participants
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: DB Month 6Population: Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug.
Percentage of participants at Month 6 with ALP \< 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.
Outcome measures
| Measure |
DB OCA 10 mg
n=73 Participants
OCA 10 mg for 12 months during the DB phase.
|
DB Placebo
n=73 Participants
Matching placebo for 12 months during the DB phase.
|
LTSE OCA (DB Placebo)
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Overall LTSE OCA
After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|
|
DB Phase: Composite Endpoint ALP And Total Bilirubin, 10 mg Versus Placebo
|
51 percentage of participants
|
7 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: DB Month 12Population: Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug.
Percentage of participants at Month 12 with ALP \< 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.
Outcome measures
| Measure |
DB OCA 10 mg
n=70 Participants
OCA 10 mg for 12 months during the DB phase.
|
DB Placebo
n=73 Participants
Matching placebo for 12 months during the DB phase.
|
LTSE OCA (DB Placebo)
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Overall LTSE OCA
After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|
|
DB Phase: Composite Endpoint ALP And Total Bilirubin, 5-10 mg Versus Placebo
|
46 percentage of participants
|
10 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: DB Month 6Population: Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug.
Percentage of participants at Month 6 with ALP \< 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.
Outcome measures
| Measure |
DB OCA 10 mg
n=70 Participants
OCA 10 mg for 12 months during the DB phase.
|
DB Placebo
n=73 Participants
Matching placebo for 12 months during the DB phase.
|
LTSE OCA (DB Placebo)
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Overall LTSE OCA
After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|
|
DB Phase: Composite Endpoint ALP And Total Bilirubin, 5-10 mg Versus Placebo
|
34 percentage of participants
|
7 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, DB Month 12Population: Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug and had an assessment at the specified timepoint.
Blood samples were evaluated for ALP levels. ALP Absolute Change From Baseline (ALP at Month 12 - ALP at Baseline) is presented.
Outcome measures
| Measure |
DB OCA 10 mg
n=64 Participants
OCA 10 mg for 12 months during the DB phase.
|
DB Placebo
n=62 Participants
Matching placebo for 12 months during the DB phase.
|
LTSE OCA (DB Placebo)
n=70 Participants
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Overall LTSE OCA
After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|
|
DB Phase: ALP Absolute Change From Baseline To Month 12
|
-112.51 U/L
Standard Error 14.36
|
-129.90 U/L
Standard Error 14.60
|
-14.42 U/L
Standard Error 14.74
|
—
|
SECONDARY outcome
Timeframe: Baseline, DB Month 12Population: Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug and had an assessment at the specified timepoint.
Blood samples were evaluated for bilirubin levels. Total bilirubin absolute change from baseline (total bilirubin at Month 12 - total bilirubin at Baseline) is presented.
Outcome measures
| Measure |
DB OCA 10 mg
n=64 Participants
OCA 10 mg for 12 months during the DB phase.
|
DB Placebo
n=62 Participants
Matching placebo for 12 months during the DB phase.
|
LTSE OCA (DB Placebo)
n=70 Participants
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Overall LTSE OCA
After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|
|
DB Phase: Total Bilirubin Absolute Change From Baseline To Month 12
|
-0.33 umol/L
Standard Error 0.68
|
-0.90 umol/L
Standard Error 0.71
|
1.98 umol/L
Standard Error 0.70
|
—
|
SECONDARY outcome
Timeframe: Baseline, DB Month 12Population: Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug and had an assessment at the specified timepoint.
Blood samples were evaluated for bilirubin levels. Direct bilirubin absolute change from baseline (direct bilirubin at Month 12 - direct bilirubin at Baseline) is presented.
Outcome measures
| Measure |
DB OCA 10 mg
n=64 Participants
OCA 10 mg for 12 months during the DB phase.
|
DB Placebo
n=62 Participants
Matching placebo for 12 months during the DB phase.
|
LTSE OCA (DB Placebo)
n=70 Participants
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Overall LTSE OCA
After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|
|
DB Phase: Direct Bilirubin Absolute Change From Baseline To Month 12
|
-0.13 umol/L
Standard Error 0.52
|
-0.49 umol/L
Standard Error 0.54
|
1.89 umol/L
Standard Error 0.53
|
—
|
SECONDARY outcome
Timeframe: Baseline, DB Month 12Population: Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug and had an assessment at the specified timepoint.
Blood samples were evaluated for ALT levels. ALT absolute change from baseline (ALT at Month 12 - ALT at Baseline) is presented.
Outcome measures
| Measure |
DB OCA 10 mg
n=64 Participants
OCA 10 mg for 12 months during the DB phase.
|
DB Placebo
n=62 Participants
Matching placebo for 12 months during the DB phase.
|
LTSE OCA (DB Placebo)
n=70 Participants
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Overall LTSE OCA
After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|
|
DB Phase: Alanine Aminotransferase (ALT) Absolute Change From Baseline To Month 12
|
-21.26 U/L
Standard Error 3.27
|
-25.31 U/L
Standard Error 3.35
|
-4.95 U/L
Standard Error 3.32
|
—
|
SECONDARY outcome
Timeframe: Baseline, DB Month 12Population: Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug and had an assessment at the specified timepoint.
Blood samples were evaluated for AST levels. AST absolute change from baseline (AST at Month 12 - AST at Baseline) is presented.
Outcome measures
| Measure |
DB OCA 10 mg
n=64 Participants
OCA 10 mg for 12 months during the DB phase.
|
DB Placebo
n=62 Participants
Matching placebo for 12 months during the DB phase.
|
LTSE OCA (DB Placebo)
n=70 Participants
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Overall LTSE OCA
After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|
|
DB Phase: Aspartate Aminotransferase (AST) Absolute Change From Baseline To Month 12
|
-13.03 U/L
Standard Error 4.17
|
-15.00 U/L
Standard Error 4.28
|
1.04 U/L
Standard Error 4.22
|
—
|
SECONDARY outcome
Timeframe: Baseline, DB Month 12Population: Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug and had an assessment at the specified timepoint.
Blood samples were evaluated for GGT levels. GGT absolute change from baseline (GGT at Month 12 - GGT at Baseline) is presented.
Outcome measures
| Measure |
DB OCA 10 mg
n=64 Participants
OCA 10 mg for 12 months during the DB phase.
|
DB Placebo
n=62 Participants
Matching placebo for 12 months during the DB phase.
|
LTSE OCA (DB Placebo)
n=70 Participants
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Overall LTSE OCA
After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|
|
DB Phase: Gamma-glutamyltransferase (GGT) Absolute Change From Baseline To Month 12
|
-140.83 U/L
Standard Error 24.70
|
-176.66 U/L
Standard Error 25.58
|
6.70 U/L
Standard Error 25.56
|
—
|
SECONDARY outcome
Timeframe: LTSE Day 0 and LTSE Months 12, 24, 36, 48, and 60Population: All participants who received at least 1 dose of OCA in the open-label safety extension phase and had an assessment at the specified timepoint.
Blood samples were evaluated for ALP levels.
Outcome measures
| Measure |
DB OCA 10 mg
n=63 Participants
OCA 10 mg for 12 months during the DB phase.
|
DB Placebo
n=64 Participants
Matching placebo for 12 months during the DB phase.
|
LTSE OCA (DB Placebo)
n=66 Participants
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Overall LTSE OCA
n=193 Participants
After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|
|
LTSE Phase: ALP Levels
LTSE Day 0
|
218.69 U/L
Standard Deviation 100.328
|
191.24 U/L
Standard Deviation 61.381
|
317.79 U/L
Standard Deviation 139.666
|
243.75 U/L
Standard Deviation 118.910
|
|
LTSE Phase: ALP Levels
LTSE Month 12
|
209.49 U/L
Standard Deviation 93.157
|
198.68 U/L
Standard Deviation 75.799
|
226.28 U/L
Standard Deviation 105.404
|
211.47 U/L
Standard Deviation 92.439
|
|
LTSE Phase: ALP Levels
LTSE Month 24
|
195.14 U/L
Standard Deviation 80.361
|
194.57 U/L
Standard Deviation 66.593
|
215.99 U/L
Standard Deviation 83.469
|
201.47 U/L
Standard Deviation 77.117
|
|
LTSE Phase: ALP Levels
LTSE Month 36
|
204.52 U/L
Standard Deviation 68.019
|
214.66 U/L
Standard Deviation 158.831
|
205.37 U/L
Standard Deviation 65.206
|
208.27 U/L
Standard Deviation 107.114
|
|
LTSE Phase: ALP Levels
LTSE Month 48
|
189.75 U/L
Standard Deviation 55.929
|
192.00 U/L
Standard Deviation 59.761
|
198.70 U/L
Standard Deviation 65.551
|
193.38 U/L
Standard Deviation 60.170
|
|
LTSE Phase: ALP Levels
LTSE Month 60
|
200.90 U/L
Standard Deviation 97.475
|
191.37 U/L
Standard Deviation 62.404
|
209.38 U/L
Standard Deviation 82.240
|
200.94 U/L
Standard Deviation 83.436
|
SECONDARY outcome
Timeframe: DB Baseline, LTSE Months 12, 24, 36, 48, and 60Population: All participants who received at least 1 dose of OCA in the open-label safety extension phase and had an assessment at the specified timepoint.
Blood samples were evaluated for ALP levels. ALP Change From Baseline (ALP at LTSE Months 12, 24, 36, 48, and 60 - ALP at Baseline) is presented. DB baseline is the mean of all available evaluations prior to DB treatment.
Outcome measures
| Measure |
DB OCA 10 mg
n=63 Participants
OCA 10 mg for 12 months during the DB phase.
|
DB Placebo
n=64 Participants
Matching placebo for 12 months during the DB phase.
|
LTSE OCA (DB Placebo)
n=66 Participants
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Overall LTSE OCA
n=193 Participants
After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|
|
LTSE Phase: ALP Change From DB Baseline
Month 12
|
-106.63 U/L
Standard Deviation 98.448
|
-104.39 U/L
Standard Deviation 82.496
|
-104.36 U/L
Standard Deviation 83.074
|
-105.13 U/L
Standard Deviation 87.882
|
|
LTSE Phase: ALP Change From DB Baseline
Month 24
|
-120.86 U/L
Standard Deviation 96.614
|
-102.52 U/L
Standard Deviation 79.413
|
-100.99 U/L
Standard Deviation 87.181
|
-108.34 U/L
Standard Deviation 87.980
|
|
LTSE Phase: ALP Change From DB Baseline
Month 36
|
-100.98 U/L
Standard Deviation 109.952
|
-84.65 U/L
Standard Deviation 137.293
|
-112.73 U/L
Standard Deviation 89.661
|
-98.96 U/L
Standard Deviation 114.635
|
|
LTSE Phase: ALP Change From DB Baseline
Month 48
|
-118.23 U/L
Standard Deviation 101.527
|
-101.50 U/L
Standard Deviation 91.335
|
-115.51 U/L
Standard Deviation 106.774
|
-111.49 U/L
Standard Deviation 99.433
|
|
LTSE Phase: ALP Change From DB Baseline
Month 60
|
-118.99 U/L
Standard Deviation 147.126
|
-117.49 U/L
Standard Deviation 95.587
|
-119.52 U/L
Standard Deviation 108.949
|
-118.74 U/L
Standard Deviation 121.391
|
Adverse Events
DB 5-10 mg
Serious events: 11 serious events
Other events: 64 other events
Deaths: 0 deaths
DB OCA 10 mg
Serious events: 8 serious events
Other events: 64 other events
Deaths: 0 deaths
DB Placebo
Serious events: 3 serious events
Other events: 62 other events
Deaths: 0 deaths
LTSE OCA (DB OCA 5-10 mg)
Serious events: 30 serious events
Other events: 61 other events
Deaths: 0 deaths
LTSE OCA (DB 10 mg)
Serious events: 19 serious events
Other events: 62 other events
Deaths: 0 deaths
LTSE OCA (DB Placebo)
Serious events: 20 serious events
Other events: 64 other events
Deaths: 0 deaths
Overall LTSE OCA
Serious events: 69 serious events
Other events: 187 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB 5-10 mg
n=70 participants at risk
OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remaining 6 months of the DB phase.
|
DB OCA 10 mg
n=73 participants at risk
OCA 10 mg for 12 months during the DB phase.
|
DB Placebo
n=73 participants at risk
Matching placebo for 12 months during the DB phase.
|
LTSE OCA (DB OCA 5-10 mg)
n=63 participants at risk
Participants previously receiving OCA 5 to 10 mg in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
LTSE OCA (DB 10 mg)
n=64 participants at risk
Participants previously receiving OCA 10 mg in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
LTSE OCA (DB Placebo)
n=66 participants at risk
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Overall LTSE OCA
n=193 participants at risk
After completion of the 12-month DB phase, all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.0%
2/193 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.0%
2/193 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Cardiac disorders
Cardiac failure
|
1.4%
1/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/193 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Eye disorders
Cataract
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.0%
2/193 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.1%
4/193 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.0%
2/193 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Splenic artery aneurysm
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
General disorders
Chest pain
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/193 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/193 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
General disorders
Oedema
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/193 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
General disorders
Polyserositis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Hepatobiliary disorders
Hyperplastic cholecystopathy
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Endocarditis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/193 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Parotitis
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.1%
4/193 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Sepsis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.0%
2/193 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.0%
2/193 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.1%
4/193 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Investigations
Medical observation
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
5/64 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.6%
7/193 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Systemic sclerosis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic obstructive pulmonary disease
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant recurrent
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm malignant stage unspecified
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal oncocytoma
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.4%
1/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/193 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Nervous system disorders
Syncope
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.0%
2/193 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Psychiatric disorders
Depression
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Psychiatric disorders
Major depression
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Renal and urinary disorders
Renal atrophy
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/193 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/193 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Vascular disorders
Hypertension
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.52%
1/193 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Vascular disorders
Varicose vein
|
2.9%
2/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.0%
2/193 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
Other adverse events
| Measure |
DB 5-10 mg
n=70 participants at risk
OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remaining 6 months of the DB phase.
|
DB OCA 10 mg
n=73 participants at risk
OCA 10 mg for 12 months during the DB phase.
|
DB Placebo
n=73 participants at risk
Matching placebo for 12 months during the DB phase.
|
LTSE OCA (DB OCA 5-10 mg)
n=63 participants at risk
Participants previously receiving OCA 5 to 10 mg in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
LTSE OCA (DB 10 mg)
n=64 participants at risk
Participants previously receiving OCA 10 mg in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
LTSE OCA (DB Placebo)
n=66 participants at risk
Participants previously receiving placebo in the DB phase received OCA in the open-label LTSE phase for up to 5 years beginning at 5 mg, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
Overall LTSE OCA
n=193 participants at risk
After completion of the 12-month DB phase, all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA, and then the dose could be titrated up. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg.
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
4/70 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
8.2%
6/73 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.8%
5/73 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
19.0%
12/63 • Number of events 23 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
17.2%
11/64 • Number of events 16 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
18.2%
12/66 • Number of events 16 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
18.1%
35/193 • Number of events 55 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
55.7%
39/70 • Number of events 93 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
68.5%
50/73 • Number of events 99 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
38.4%
28/73 • Number of events 49 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
77.8%
49/63 • Number of events 249 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
79.7%
51/64 • Number of events 198 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
75.8%
50/66 • Number of events 180 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
77.7%
150/193 • Number of events 627 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
3/70 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.5%
4/73 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
11.1%
7/63 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
5/64 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.3%
14/193 • Number of events 16 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.7%
4/70 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.9%
5/63 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.2%
4/64 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.6%
5/66 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.3%
14/193 • Number of events 16 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Nasopharyngitis
|
24.3%
17/70 • Number of events 27 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
17.8%
13/73 • Number of events 15 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
17.8%
13/73 • Number of events 19 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
36.5%
23/63 • Number of events 66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
35.9%
23/64 • Number of events 39 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
16.7%
11/66 • Number of events 22 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
29.5%
57/193 • Number of events 127 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Urinary tract infection
|
5.7%
4/70 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.5%
4/73 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
11.0%
8/73 • Number of events 15 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
27.0%
17/63 • Number of events 31 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
29.7%
19/64 • Number of events 27 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
22.7%
15/66 • Number of events 23 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
26.4%
51/193 • Number of events 81 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
4/70 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.5%
4/73 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
11.0%
8/73 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
19.0%
12/63 • Number of events 21 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
17.2%
11/64 • Number of events 17 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
16.7%
11/66 • Number of events 16 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
17.6%
34/193 • Number of events 54 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Influenza
|
7.1%
5/70 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.5%
4/73 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.5%
4/73 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
19.0%
12/63 • Number of events 17 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
18.8%
12/64 • Number of events 17 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
15.2%
10/66 • Number of events 17 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
17.6%
34/193 • Number of events 51 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Sinusitis
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.5%
4/73 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
11.1%
7/63 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
14.1%
9/64 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
12.1%
8/66 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
12.4%
24/193 • Number of events 29 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Bronchitis
|
5.7%
4/70 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
11.1%
7/63 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.9%
7/64 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.1%
6/66 • Number of events 10 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.4%
20/193 • Number of events 24 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Nausea
|
5.7%
4/70 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
11.0%
8/73 • Number of events 10 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
12.3%
9/73 • Number of events 18 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
22.2%
14/63 • Number of events 20 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
20.3%
13/64 • Number of events 19 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
15.2%
10/66 • Number of events 15 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
19.2%
37/193 • Number of events 54 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
2/70 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
11.0%
8/73 • Number of events 10 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
11.0%
8/73 • Number of events 13 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
12.7%
8/63 • Number of events 15 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
17.2%
11/64 • Number of events 17 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
21.2%
14/66 • Number of events 26 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
17.1%
33/193 • Number of events 58 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
5/70 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.5%
4/73 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.8%
5/73 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
14.3%
9/63 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
15.6%
10/64 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
18.2%
12/66 • Number of events 13 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
16.1%
31/193 • Number of events 36 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Constipation
|
7.1%
5/70 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.8%
5/73 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.5%
4/73 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
19.0%
12/63 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
14.1%
9/64 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.6%
7/66 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
14.5%
28/193 • Number of events 29 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Abdominal distension
|
4.3%
3/70 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.6%
7/73 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.9%
5/63 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.9%
7/64 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.6%
5/66 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
8.8%
17/193 • Number of events 19 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
4/70 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
11.0%
8/73 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
11.1%
7/63 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
12.5%
8/64 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.6%
5/66 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.4%
20/193 • Number of events 25 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
3/70 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.8%
5/73 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.9%
5/63 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.9%
7/64 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.3%
14/193 • Number of events 18 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
2/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.5%
4/73 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.5%
4/73 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
11.1%
7/63 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
14.1%
9/64 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.1%
4/66 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.4%
20/193 • Number of events 23 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
3/70 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
8.2%
6/73 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
17.5%
11/63 • Number of events 15 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.9%
7/64 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
12.1%
8/66 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
13.5%
26/193 • Number of events 32 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.1%
5/70 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.9%
5/63 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.6%
7/193 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
General disorders
Fatigue
|
15.7%
11/70 • Number of events 13 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
23.3%
17/73 • Number of events 25 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
13.7%
10/73 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
38.1%
24/63 • Number of events 46 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
37.5%
24/64 • Number of events 43 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
22.7%
15/66 • Number of events 20 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
32.6%
63/193 • Number of events 109 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
General disorders
Oedema peripheral
|
2.9%
2/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.8%
5/73 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
15.9%
10/63 • Number of events 15 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
12.5%
8/64 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
12.1%
8/66 • Number of events 10 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
13.5%
26/193 • Number of events 37 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
General disorders
Pyrexia
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.8%
5/73 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.9%
5/63 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.4%
6/64 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.6%
5/66 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
8.3%
16/193 • Number of events 19 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
4/70 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.5%
4/73 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
11.0%
8/73 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
15.9%
10/63 • Number of events 13 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
17.2%
11/64 • Number of events 15 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
15.2%
10/66 • Number of events 10 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
16.1%
31/193 • Number of events 38 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
4/70 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.6%
7/73 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
22.2%
14/63 • Number of events 17 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
26.6%
17/64 • Number of events 23 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
22.7%
15/66 • Number of events 18 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
23.8%
46/193 • Number of events 58 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.9%
2/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.5%
4/73 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.3%
4/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.2%
4/64 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.7%
11/193 • Number of events 14 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Nervous system disorders
Headache
|
17.1%
12/70 • Number of events 26 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
8.2%
6/73 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
17.8%
13/73 • Number of events 16 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
31.7%
20/63 • Number of events 43 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
23.4%
15/64 • Number of events 22 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
13.6%
9/66 • Number of events 10 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
22.8%
44/193 • Number of events 75 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
5/70 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
8.2%
6/73 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.5%
6/63 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
12.5%
8/64 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.1%
4/66 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.3%
18/193 • Number of events 23 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Psychiatric disorders
Insomnia
|
2.9%
2/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.6%
7/73 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.5%
6/63 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.9%
7/64 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.6%
7/66 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.4%
20/193 • Number of events 24 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Eye disorders
Dry eye
|
2.9%
2/70 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.5%
4/73 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.5%
4/73 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
15.6%
10/64 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
15/193 • Number of events 17 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
2/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.5%
4/73 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
12.7%
8/63 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.9%
7/64 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.1%
4/66 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.8%
19/193 • Number of events 25 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Cardiac disorders
Palpitations
|
2.9%
2/70 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.8%
5/73 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.3%
4/63 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
5/64 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.7%
11/193 • Number of events 13 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.7%
4/70 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
12.7%
8/63 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.2%
4/64 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.1%
4/66 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
8.3%
16/193 • Number of events 21 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Endocrine disorders
Hypothyroidism
|
5.7%
4/70 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.3%
4/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.2%
10/193 • Number of events 10 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
14.3%
9/63 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.4%
6/64 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.1%
6/66 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.9%
21/193 • Number of events 22 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
3/70 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
11.1%
7/63 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
5/64 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
12.1%
8/66 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.4%
20/193 • Number of events 25 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Vascular disorders
Hypertension
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.9%
5/63 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.4%
6/64 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
12.1%
8/66 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.8%
19/193 • Number of events 21 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.3%
4/63 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.4%
6/64 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.6%
5/66 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
15/193 • Number of events 20 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Nervous system disorders
Dizziness
|
4.3%
3/70 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.9%
5/63 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.9%
7/64 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.3%
14/193 • Number of events 18 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
5/64 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.1%
6/66 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.3%
14/193 • Number of events 20 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Psychiatric disorders
Depression
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.9%
5/63 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
5/64 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.7%
13/193 • Number of events 16 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.3%
4/63 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.9%
7/64 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.7%
13/193 • Number of events 16 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.9%
5/63 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.2%
4/64 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.1%
4/66 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.7%
13/193 • Number of events 16 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Cystitis
|
1.4%
1/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.9%
5/63 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
5/64 • Number of events 15 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.2%
12/193 • Number of events 30 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
10.9%
7/64 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.1%
4/66 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.2%
12/193 • Number of events 13 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.3%
4/63 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
5/64 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.2%
12/193 • Number of events 14 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.2%
4/64 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.6%
5/66 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.2%
12/193 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
5/64 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.6%
5/66 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.2%
12/193 • Number of events 16 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
General disorders
Asthenia
|
2.9%
2/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.1%
6/66 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.7%
11/193 • Number of events 15 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Dry mouth
|
2.9%
2/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
5/64 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.7%
11/193 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.4%
6/64 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.7%
11/193 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.9%
5/63 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.6%
5/66 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.7%
11/193 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
General disorders
Influenza like illness
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.3%
4/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.4%
6/64 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.7%
11/193 • Number of events 14 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.2%
4/64 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.6%
5/66 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.7%
11/193 • Number of events 13 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Varices oesophageal
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
12.7%
8/63 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.7%
11/193 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.5%
6/63 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.2%
10/193 • Number of events 14 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.9%
2/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.9%
5/63 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.2%
4/64 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.2%
10/193 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Contusion
|
4.3%
3/70 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
5/64 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.2%
10/193 • Number of events 10 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Gastroenteritis
|
4.3%
3/70 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.3%
4/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.6%
5/66 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.2%
10/193 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
5/64 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
5.2%
10/193 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Dental caries
|
2.9%
2/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.3%
4/63 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.1%
4/66 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
9/193 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.6%
5/66 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
9/193 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
9/193 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.6%
5/193 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.2%
4/64 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.6%
5/193 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.6%
5/193 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Diverticulum
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.6%
5/193 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Ear infection
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.6%
5/193 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.6%
5/193 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.6%
5/193 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.6%
5/193 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.6%
5/193 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Oral herpes
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.6%
5/193 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.6%
5/193 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.6%
5/193 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.6%
5/193 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.6%
5/193 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.1%
4/66 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.1%
4/193 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.1%
4/193 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.1%
4/193 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.1%
4/193 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.1%
4/193 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.1%
4/193 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
4.3%
3/70 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.1%
4/193 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.1%
4/193 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.1%
4/193 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
3/193 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
3/193 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Nervous system disorders
Hypoaesthesia
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
3/193 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
3/193 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/66 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
3/193 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Scratch
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
9.4%
6/64 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
9/193 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Eye disorders
Conjunctivitis
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
5/64 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
8/193 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
2/70 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
8/193 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
8/193 • Number of events 12 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.3%
4/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/64 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.1%
4/66 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
8/193 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
8/193 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Vascular disorders
Hypotension
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.1%
4/66 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
8/193 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.1%
4/66 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
8/193 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Ear and labyrinth disorders
Vertigo
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.3%
4/63 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
8/193 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
8/193 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Psychiatric disorders
Anxiety
|
2.9%
2/70 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.6%
7/193 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Cardiac disorders
Cardiac murmur
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.6%
7/193 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.1%
3/73 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.2%
4/64 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.6%
7/193 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.1%
4/66 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.6%
7/193 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
7.8%
5/64 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.6%
7/193 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Nervous system disorders
Paraesthesia
|
1.4%
1/70 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.6%
7/193 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.1%
4/66 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.6%
7/193 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Immune system disorders
Seasonal allergy
|
2.9%
2/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.7%
2/73 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.3%
4/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.6%
7/193 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.3%
4/63 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.6%
7/193 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Tooth infection
|
1.4%
1/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.6%
7/193 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
6/193 • Number of events 10 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Eye disorders
Cataract
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
6/193 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/63 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.5%
3/66 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
6/193 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Ear and labyrinth disorders
Ear pain
|
2.9%
2/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
6/193 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Lower respiratory tract infection
|
2.9%
2/70 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
6.3%
4/63 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 5 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
6/193 • Number of events 15 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/63 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
6/193 • Number of events 9 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.2%
2/63 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.7%
3/64 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
6/193 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Psychiatric disorders
Sleep disorder
|
4.3%
3/70 • Number of events 7 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 8 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.0%
2/66 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
6/193 • Number of events 11 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Investigations
Weight decreased
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 3 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
2/64 • Number of events 2 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
3.1%
6/193 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/70 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.4%
1/73 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
0.00%
0/73 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
4.8%
3/63 • Number of events 4 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.6%
1/64 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
1.5%
1/66 • Number of events 1 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
2.6%
5/193 • Number of events 6 • DB Phase: Baseline up to 12 months (1 year). LTSE phase: Baseline (DB Month 12) up to 60 months (5 years).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators must wait 18 months after the study ends to publish their results and a multi-center publication must come first. The sponsor has a 45 day review period with the option to extend to an additional 90 days.
- Publication restrictions are in place
Restriction type: OTHER