Trial Outcomes & Findings for An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density (NCT NCT00325468)
NCT ID: NCT00325468
Last Updated: 2017-08-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
200 participants
Primary outcome timeframe
8 years
Results posted on
2017-08-01
Participant Flow
Subjects who successfully completed the double-blind, randomized, 4-year dose-ranging parent study 20010223
Participant milestones
| Measure |
Placebo
In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
|
Denosumab 210 mg Q6M
In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
|
Denosumab 30 mg Q3M
In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
|
Denosumab Continuous Treatment
In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
|
Alendronate 70mg QW
In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
17
|
14
|
124
|
22
|
|
Overall Study
COMPLETED
|
12
|
12
|
10
|
90
|
14
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
4
|
34
|
8
|
Reasons for withdrawal
| Measure |
Placebo
In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
|
Denosumab 210 mg Q6M
In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
|
Denosumab 30 mg Q3M
In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
|
Denosumab Continuous Treatment
In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
|
Alendronate 70mg QW
In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
5
|
1
|
|
Overall Study
Death
|
2
|
0
|
2
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
0
|
14
|
4
|
|
Overall Study
site closure etc
|
4
|
2
|
1
|
8
|
1
|
Baseline Characteristics
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
Baseline characteristics by cohort
| Measure |
Placebo
n=23 Participants
In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
|
Denosumab 210 mg Q6M
n=17 Participants
In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
|
Denosumab 30 mg Q3M
n=14 Participants
In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
|
Denosumab Continuous Treatment
n=124 Participants
In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
|
Alendronate 70mg QW
n=22 Participants
In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.8 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
65.8 Years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
68.0 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
65.8 Years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
66.6 Years
STANDARD_DEVIATION 8.9 • n=21 Participants
|
66.1 Years
STANDARD_DEVIATION 7.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
200 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
178 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Aborigine
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Baseline Bone Mineral Density T-score of Each Anatomic Site
Lumbar spine BMD T-score
|
-2.36 T-score
STANDARD_DEVIATION 0.62 • n=5 Participants
|
-2.02 T-score
STANDARD_DEVIATION 1.16 • n=7 Participants
|
-1.29 T-score
STANDARD_DEVIATION 0.94 • n=5 Participants
|
-1.35 T-score
STANDARD_DEVIATION 0.87 • n=4 Participants
|
-1.64 T-score
STANDARD_DEVIATION 1.09 • n=21 Participants
|
-1.55 T-score
STANDARD_DEVIATION 0.96 • n=8 Participants
|
|
Baseline Bone Mineral Density T-score of Each Anatomic Site
Total hip BMD T-score
|
-1.63 T-score
STANDARD_DEVIATION 0.75 • n=5 Participants
|
-1.39 T-score
STANDARD_DEVIATION 0.67 • n=7 Participants
|
-1.05 T-score
STANDARD_DEVIATION 0.75 • n=5 Participants
|
-1.08 T-score
STANDARD_DEVIATION 0.68 • n=4 Participants
|
-1.50 T-score
STANDARD_DEVIATION 0.81 • n=21 Participants
|
-1.21 T-score
STANDARD_DEVIATION 0.73 • n=8 Participants
|
|
Baseline Bone Mineral Density T-score of Each Anatomic Site
Distal 1/3 radius T-score
|
-1.91 T-score
STANDARD_DEVIATION 1.25 • n=5 Participants
|
-1.45 T-score
STANDARD_DEVIATION 0.98 • n=7 Participants
|
-1.14 T-score
STANDARD_DEVIATION 1.29 • n=5 Participants
|
-1.23 T-score
STANDARD_DEVIATION 1.21 • n=4 Participants
|
-1.57 T-score
STANDARD_DEVIATION 0.98 • n=21 Participants
|
-1.35 T-score
STANDARD_DEVIATION 1.19 • n=8 Participants
|
PRIMARY outcome
Timeframe: 8 yearsPopulation: Subjects with nonmissing value at parent study 20010223 baseline and Year 8
Outcome measures
| Measure |
Placebo
n=12 Participants
In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
|
Denosumab 210 mg Q6M
n=12 Participants
In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
|
Denosumab 30 mg Q3M
n=8 Participants
In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
|
Denosumab Continuous Treatment
n=88 Participants
In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
|
Alendronate 70mg QW
n=13 Participants
In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
|
|---|---|---|---|---|---|
|
Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
|
8.4 percent
Interval 4.4 to 12.4
|
11.2 percent
Interval 7.2 to 15.2
|
11.0 percent
Interval 6.0 to 16.0
|
16.5 percent
Interval 14.9 to 18.1
|
12.4 percent
Interval 8.5 to 16.4
|
PRIMARY outcome
Timeframe: 8 yearsPopulation: Subjects with nonmissing value at parent study 20010223 baseline and Year 8
Outcome measures
| Measure |
Placebo
n=12 Participants
In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
|
Denosumab 210 mg Q6M
n=12 Participants
In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
|
Denosumab 30 mg Q3M
n=9 Participants
In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
|
Denosumab Continuous Treatment
n=87 Participants
In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
|
Alendronate 70mg QW
n=13 Participants
In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
|
|---|---|---|---|---|---|
|
Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
|
1.1 percent
Interval -1.2 to 3.5
|
4.3 percent
Interval 2.0 to 6.6
|
2.3 percent
Interval -0.5 to 5.1
|
6.8 percent
Interval 5.8 to 7.7
|
3.4 percent
Interval 1.1 to 5.7
|
PRIMARY outcome
Timeframe: 8 yearsPopulation: Subjects with nonmissing value at parent study 20010223 baseline and Year 8
Outcome measures
| Measure |
Placebo
n=11 Participants
In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
|
Denosumab 210 mg Q6M
n=10 Participants
In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
|
Denosumab 30 mg Q3M
n=9 Participants
In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
|
Denosumab Continuous Treatment
n=87 Participants
In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
|
Alendronate 70mg QW
n=13 Participants
In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
|
|---|---|---|---|---|---|
|
Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
|
-5.2 percent
Interval -7.4 to -2.9
|
1.4 percent
Interval -0.9 to 3.8
|
0.6 percent
Interval -1.9 to 3.1
|
1.3 percent
Interval 0.5 to 2.2
|
-2.2 percent
Interval -4.3 to -0.1
|
SECONDARY outcome
Timeframe: 8 yearsPopulation: Subjects with nonmissing value at parent study 20010223 baseline and Year 8
Outcome measures
| Measure |
Placebo
n=12 Participants
In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
|
Denosumab 210 mg Q6M
n=12 Participants
In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
|
Denosumab 30 mg Q3M
n=10 Participants
In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
|
Denosumab Continuous Treatment
n=90 Participants
In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
|
Alendronate 70mg QW
n=14 Participants
In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
|
|---|---|---|---|---|---|
|
Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8
|
-55.8 percent
Interval -66.7 to -24.4
|
-44.7 percent
Interval -63.6 to -23.8
|
-52.5 percent
Interval -60.4 to -27.1
|
-44.4 percent
Interval -61.9 to -10.2
|
-54.2 percent
Interval -65.1 to -24.9
|
SECONDARY outcome
Timeframe: 8 yearsPopulation: Subjects with nonmissing value at parent study 20010223 baseline and Year 8
Outcome measures
| Measure |
Placebo
n=12 Participants
In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
|
Denosumab 210 mg Q6M
n=13 Participants
In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
|
Denosumab 30 mg Q3M
n=10 Participants
In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
|
Denosumab Continuous Treatment
n=89 Participants
In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
|
Alendronate 70mg QW
n=13 Participants
In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
|
|---|---|---|---|---|---|
|
Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8
|
-66.4 percent
Interval -90.8 to -27.3
|
-72.0 percent
Interval -84.9 to -57.4
|
-48.0 percent
Interval -87.9 to 26.8
|
-64.6 percent
Interval -77.3 to -2.7
|
-49.8 percent
Interval -82.0 to -45.4
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Denosumab 210 mg Q6M
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Denosumab 30 mg Q3M
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Denosumab Continuous Treatment
Serious events: 31 serious events
Other events: 106 other events
Deaths: 0 deaths
Alendronate 70 mg QW
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
All Participants
Serious events: 45 serious events
Other events: 171 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=23 participants at risk
In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
|
Denosumab 210 mg Q6M
n=17 participants at risk
In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
|
Denosumab 30 mg Q3M
n=14 participants at risk
In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
|
Denosumab Continuous Treatment
n=124 participants at risk
In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
|
Alendronate 70 mg QW
n=22 participants at risk
|
All Participants
n=200 participants at risk
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Haematoma
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest discomfort
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest pain
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Death
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
3/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Performance status decreased
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pyrexia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Weight decreased
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.0%
4/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastrointestinal neoplasm
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage I
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage III
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IIIB
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Coma
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Syncope
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Placebo
n=23 participants at risk
In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
|
Denosumab 210 mg Q6M
n=17 participants at risk
In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
|
Denosumab 30 mg Q3M
n=14 participants at risk
In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
|
Denosumab Continuous Treatment
n=124 participants at risk
In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
|
Alendronate 70 mg QW
n=22 participants at risk
|
All Participants
n=200 participants at risk
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
3/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.0%
4/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Palpitations
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.5%
5/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Vertigo
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.0%
5/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.5%
7/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Endocrine disorders
Hypothyroidism
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.8%
2/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.0%
6/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Cataract
|
13.0%
3/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
10.5%
13/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.6%
3/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.0%
22/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Diplopia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Dry eye
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.0%
6/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Eye pain
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Eye swelling
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Glaucoma
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.2%
4/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
2/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.0%
6/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.8%
2/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.2%
4/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.0%
8/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.8%
2/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
3/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.6%
3/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
9/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.8%
2/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
3/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.5%
7/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.8%
6/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
2/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.5%
11/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.5%
5/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.8%
6/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.5%
11/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Fatigue
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
7/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
2/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.5%
11/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Malaise
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Medical device complication
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.5%
5/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Oedema peripheral
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
7/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
9/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pyrexia
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bronchitis
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
23.5%
4/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
7/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.5%
17/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Fungal oesophagitis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
3/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.5%
5/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Influenza
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.0%
5/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.6%
3/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.0%
10/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Localised infection
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.1%
10/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
2/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.5%
15/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sinusitis
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.5%
18/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.5%
23/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Skin infection
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Staphylococcal infection
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
39.1%
9/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
41.2%
7/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
19.4%
24/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.6%
3/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
22.5%
45/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.1%
15/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
2/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
10.0%
20/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Viral infection
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.5%
8/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.5%
11/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Excoriation
|
13.0%
3/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.0%
4/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.3%
9/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.5%
13/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Gastrointestinal injury
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
3/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.0%
4/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
7/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.6%
3/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.5%
15/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Weight decreased
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.8%
2/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
3/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
2/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.5%
7/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.4%
4/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
23.5%
4/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
28.6%
4/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
16.1%
20/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
22.7%
5/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.5%
37/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.0%
3/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
23.5%
4/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.3%
14/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.6%
3/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.5%
25/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.8%
6/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.0%
8/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
3/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.5%
5/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
17.4%
4/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
7/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.5%
13/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
17.4%
4/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.3%
9/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.0%
14/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.2%
4/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.5%
5/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
2/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.0%
6/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.0%
5/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
9/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
23.5%
4/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.3%
14/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.6%
3/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.5%
23/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Trendelenburg's symptom
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.5%
8/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.5%
11/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.8%
6/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.0%
8/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.5%
8/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.0%
10/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Migraine
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
3/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.5%
5/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.2%
4/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.0%
6/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Syncope
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
3/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.0%
4/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Depression
|
13.0%
3/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
17.6%
3/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.8%
6/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.1%
2/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.0%
14/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.7%
12/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.0%
14/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal failure
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
3/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.0%
8/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.0%
4/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.3%
1/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.2%
4/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.0%
6/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.0%
4/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.0%
2/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.5%
3/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.8%
2/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
2/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.0%
6/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.81%
1/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
1/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.5%
5/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypertension
|
8.7%
2/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
17.6%
3/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
28.6%
4/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
10.5%
13/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.6%
3/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.5%
25/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/23 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/124 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/22 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.50%
1/200 • 48 months (i.e., 4 years during the 20050233 extension study)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER