Trial Outcomes & Findings for A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis (NCT NCT00541658)
NCT ID: NCT00541658
Last Updated: 2013-04-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
923 participants
Primary outcome timeframe
52 weeks / Endpoint
Results posted on
2013-04-22
Participant Flow
923 women with PMO at 43 sites in 8 countries across North America, South America, and the European Union. Patients were randomized within a site to 1 of 3 treatment groups (35 mg delayed-release Risedronate, given once-weekly before/after breakfast, and 5 mg immediate-release Risedronate, administered once-daily before breakfast) in a 1:1:1 ratio.
Participant milestones
| Measure |
5 mg Before Breakfast
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Overall Study
STARTED
|
308
|
307
|
308
|
|
Overall Study
ITT Population
|
307
|
307
|
308
|
|
Overall Study
COMPLETED
|
248
|
234
|
240
|
|
Overall Study
NOT COMPLETED
|
60
|
73
|
68
|
Reasons for withdrawal
| Measure |
5 mg Before Breakfast
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
28
|
37
|
25
|
|
Overall Study
Physician Decision
|
0
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
6
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
28
|
32
|
32
|
|
Overall Study
Took No Study Drug
|
1
|
0
|
0
|
Baseline Characteristics
A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
Baseline characteristics by cohort
| Measure |
5 mg Before Breakfast
n=308 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=307 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=308 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
Total
n=923 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Gender
Female
|
307 participants
n=5 Participants
|
307 participants
n=7 Participants
|
308 participants
n=5 Participants
|
922 participants
n=4 Participants
|
|
Gender
Male
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
88 participants
n=5 Participants
|
85 participants
n=7 Participants
|
84 participants
n=5 Participants
|
257 participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Region of Enrollment
Estonia
|
53 participants
n=5 Participants
|
53 participants
n=7 Participants
|
52 participants
n=5 Participants
|
158 participants
n=4 Participants
|
|
Region of Enrollment
France
|
19 participants
n=5 Participants
|
23 participants
n=7 Participants
|
18 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
35 participants
n=5 Participants
|
34 participants
n=7 Participants
|
33 participants
n=5 Participants
|
102 participants
n=4 Participants
|
|
Age Continuous
|
65.3 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
65.8 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
66.0 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
|
Age, Customized
< 65 years
|
141 participants
n=5 Participants
|
127 participants
n=7 Participants
|
133 participants
n=5 Participants
|
401 participants
n=4 Participants
|
|
Age, Customized
Between 65 and < 75 years
|
128 participants
n=5 Participants
|
141 participants
n=7 Participants
|
133 participants
n=5 Participants
|
402 participants
n=4 Participants
|
|
Age, Customized
> = 75 years
|
38 participants
n=5 Participants
|
39 participants
n=7 Participants
|
42 participants
n=5 Participants
|
119 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
56 participants
n=5 Participants
|
57 participants
n=7 Participants
|
58 participants
n=5 Participants
|
171 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
43 participants
n=7 Participants
|
51 participants
n=5 Participants
|
140 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 52 weeks / EndpointPopulation: Intention-to-Treat (ITT) Population. Last Observation Carried Forward (LOCF) at Week 52.
Outcome measures
| Measure |
5 mg Before Breakfast
n=270 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=261 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=271 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population
|
3.069 Percent Change
Interval 2.664 to 3.474
|
3.302 Percent Change
Interval 2.89 to 3.715
|
3.365 Percent Change
Interval 2.961 to 3.769
|
SECONDARY outcome
Timeframe: Week 52 / EndpointPopulation: 35 mg group combined delayed-relase following breakfast (DRFB) group with delayed-relase before breakfast (DRBB) group and compared with 5 mg immediate-release before breakfast (IRBB) group. ITT Population. Last Observation Carried Forward at Week 52.
Outcome measures
| Measure |
5 mg Before Breakfast
n=270 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=532 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population
|
3.069 Percent Change
Interval 2.664 to 3.474
|
3.334 Percent Change
Interval 3.046 to 3.622
|
—
|
SECONDARY outcome
Timeframe: Week 26Population: ITT Population
Outcome measures
| Measure |
5 mg Before Breakfast
n=269 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=261 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=269 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population
|
2.685 Percent Change
Interval 2.305 to 3.066
|
2.816 Percent Change
Interval 2.429 to 3.203
|
2.529 Percent Change
Interval 2.148 to 2.91
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population
Outcome measures
| Measure |
5 mg Before Breakfast
n=258 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=257 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=258 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population
|
3.035 Percent Change
Interval 2.627 to 3.443
|
3.293 Percent Change
Interval 2.883 to 3.702
|
3.357 Percent Change
Interval 2.949 to 3.766
|
SECONDARY outcome
Timeframe: Week 104Population: ITT Population
Outcome measures
| Measure |
5 mg Before Breakfast
n=242 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=232 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=235 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population
|
4.352 Percent Change
Interval 3.829 to 4.874
|
5.506 Percent Change
Interval 4.971 to 6.04
|
5.396 Percent Change
Interval 4.865 to 5.926
|
SECONDARY outcome
Timeframe: Week 104 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 104.
Outcome measures
| Measure |
5 mg Before Breakfast
n=274 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=265 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=273 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population
|
4.147 Percent Change
Interval 3.653 to 4.64
|
5.205 Percent Change
Interval 4.703 to 5.707
|
5.068 Percent Change
Interval 4.574 to 5.562
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population.
Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Outcome measures
| Measure |
5 mg Before Breakfast
n=258 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=257 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=258 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population
|
81 Percentage of Participants
|
87.5 Percentage of Participants
|
86.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 52 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 52.
Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Outcome measures
| Measure |
5 mg Before Breakfast
n=270 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=261 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=271 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population
|
81.5 Percentage of Participants
|
87.4 Percentage of Participants
|
86.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population
Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Outcome measures
| Measure |
5 mg Before Breakfast
n=242 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=232 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=235 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population
|
82.6 Percentage of Participants
|
89.2 Percentage of Participants
|
92.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 52 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 104.
Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Outcome measures
| Measure |
5 mg Before Breakfast
n=274 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=265 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=273 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population
|
81.8 Percentage of Participants
|
87.9 Percentage of Participants
|
90.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 26Population: ITT Population.
Outcome measures
| Measure |
5 mg Before Breakfast
n=273 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=267 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=275 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population
|
1.613 Percent Change
Interval 1.354 to 1.872
|
1.748 Percent Change
Interval 1.486 to 2.01
|
1.685 Percent Change
Interval 1.426 to 1.943
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population.
Outcome measures
| Measure |
5 mg Before Breakfast
n=258 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=256 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=258 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population
|
1.809 Percent
Interval 1.524 to 2.093
|
2.130 Percent
Interval 1.845 to 2.415
|
2.099 Percent
Interval 1.815 to 2.383
|
SECONDARY outcome
Timeframe: Week 52 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 52.
Outcome measures
| Measure |
5 mg Before Breakfast
n=279 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=274 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=280 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population
|
1.785 Percent Change
Interval 1.508 to 2.062
|
2.073 Percent Change
Interval 1.793 to 2.352
|
2.075 Percent Change
Interval 1.799 to 2.352
|
SECONDARY outcome
Timeframe: Week 104Population: ITT Population
Outcome measures
| Measure |
5 mg Before Breakfast
n=244 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=231 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=239 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population
|
2.177 Percent Change
Interval 1.805 to 2.549
|
2.821 Percent Change
Interval 2.438 to 3.204
|
2.764 Percent Change
Interval 2.389 to 3.14
|
SECONDARY outcome
Timeframe: Week 104 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 104.
Outcome measures
| Measure |
5 mg Before Breakfast
n=279 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=274 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=280 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population
|
2.028 Percent Change
Interval 1.671 to 2.386
|
2.551 Percent Change
Interval 2.19 to 2.912
|
2.496 Percent Change
Interval 2.139 to 2.853
|
SECONDARY outcome
Timeframe: Week 26Population: ITT Population
Outcome measures
| Measure |
5 mg Before Breakfast
n=273 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=267 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=275 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population
|
1.120 Percent Change
Interval 0.792 to 1.447
|
1.385 Percent Change
Interval 1.053 to 1.716
|
1.246 Percent Change
Interval 0.92 to 1.572
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population
Outcome measures
| Measure |
5 mg Before Breakfast
n=258 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=256 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=258 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population
|
1.155 Percent Change
Interval 0.814 to 1.496
|
1.482 Percent Change
Interval 1.14 to 1.825
|
1.717 Percent Change
Interval 1.376 to 2.058
|
SECONDARY outcome
Timeframe: Week 52 / EndpointPopulation: ITT Population. LOCF at Week 52.
Outcome measures
| Measure |
5 mg Before Breakfast
n=279 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=274 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=280 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population
|
1.180 Percent Change
Interval 0.853 to 1.507
|
1.507 Percent Change
Interval 1.177 to 1.838
|
1.717 Percent Change
Interval 1.39 to 2.044
|
SECONDARY outcome
Timeframe: Week 104Population: ITT Population
Outcome measures
| Measure |
5 mg Before Breakfast
n=244 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=231 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=239 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population
|
1.530 Percent Change
Interval 1.105 to 1.955
|
2.108 Percent Change
Interval 1.67 to 2.545
|
2.328 Percent Change
Interval 1.899 to 2.758
|
SECONDARY outcome
Timeframe: Week 104 / EndpointPopulation: ITT Population. LOCF at Week 104.
Outcome measures
| Measure |
5 mg Before Breakfast
n=279 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=274 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=280 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population
|
1.431 Percent Change
Interval 1.028 to 1.834
|
1.986 Percent Change
Interval 1.579 to 2.393
|
2.047 Percent Change
Interval 1.644 to 2.449
|
SECONDARY outcome
Timeframe: Week 26Population: ITT Population.
Outcome measures
| Measure |
5 mg Before Breakfast
n=273 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=267 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=275 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population
|
1.900 Percent Change
Interval 1.47 to 2.329
|
2.148 Percent Change
Interval 1.713 to 2.583
|
2.164 Percent Change
Interval 1.736 to 2.592
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population.
Outcome measures
| Measure |
5 mg Before Breakfast
n=258 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=256 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=258 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population
|
2.297 Percent Change
Interval 1.854 to 2.74
|
2.854 Percent Change
Interval 2.409 to 3.299
|
2.819 Percent Change
Interval 2.376 to 3.262
|
SECONDARY outcome
Timeframe: Week 52 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 52.
Outcome measures
| Measure |
5 mg Before Breakfast
n=279 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=274 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=280 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint
|
2.186 Percent Change
Interval 1.746 to 2.625
|
2.732 Percent Change
Interval 2.288 to 3.175
|
2.764 Percent Change
Interval 2.326 to 3.203
|
SECONDARY outcome
Timeframe: Week 104Population: ITT Population.
Outcome measures
| Measure |
5 mg Before Breakfast
n=244 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=231 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=239 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population
|
3.056 Percent Change
Interval 2.523 to 3.589
|
4.152 Percent Change
Interval 3.603 to 4.7
|
4.246 Percent Change
Interval 3.707 to 4.785
|
SECONDARY outcome
Timeframe: Week 104 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 104.
Outcome measures
| Measure |
5 mg Before Breakfast
n=279 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=274 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=280 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint
|
2.772 Percent Change
Interval 2.255 to 3.289
|
3.691 Percent Change
Interval 3.169 to 4.213
|
3.828 Percent Change
Interval 3.312 to 4.344
|
SECONDARY outcome
Timeframe: Week 13Population: ITT Population
Outcome measures
| Measure |
5 mg Before Breakfast
n=278 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=273 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=275 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population
|
-42.595 Percent Change
Interval -45.869 to -39.32
|
-46.366 Percent Change
Interval -49.673 to -43.059
|
-45.420 Percent Change
Interval -48.714 to -42.126
|
SECONDARY outcome
Timeframe: Week 26Population: ITT Population
Outcome measures
| Measure |
5 mg Before Breakfast
n=271 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=265 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=272 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population
|
-43.075 Percent Change
Interval -46.449 to -39.702
|
-45.705 Percent Change
Interval -49.119 to -42.291
|
-47.692 Percent Change
Interval -51.062 to -44.323
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population
Outcome measures
| Measure |
5 mg Before Breakfast
n=256 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=253 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=257 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population
|
-42.223 Percent Change
Interval -45.71 to -38.735
|
-47.263 Percent Change
Interval -50.771 to -43.754
|
-46.863 Percent Change
Interval -50.345 to -43.38
|
SECONDARY outcome
Timeframe: Week 52 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 52.
Outcome measures
| Measure |
5 mg Before Breakfast
n=279 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=274 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=278 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population
|
-40.227 Percent Change
Interval -43.773 to -36.68
|
-46.599 Percent Change
Interval -50.18 to -43.017
|
-44.630 Percent Change
Interval -48.185 to -41.075
|
SECONDARY outcome
Timeframe: Week 104Population: ITT Population.
Outcome measures
| Measure |
5 mg Before Breakfast
n=242 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=234 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=236 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population
|
-49.188 Percent Change
Interval -53.061 to -45.314
|
-53.927 Percent Change
Interval -57.87 to -49.983
|
-53.186 Percent Change
Interval -57.111 to -49.261
|
SECONDARY outcome
Timeframe: Week 104 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 104.
Outcome measures
| Measure |
5 mg Before Breakfast
n=279 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=274 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=278 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population
|
-46.261 Percent Change
Interval -50.137 to -42.386
|
-51.079 Percent Change
Interval -54.993 to -47.165
|
-49.454 Percent Change
Interval -53.338 to -45.569
|
SECONDARY outcome
Timeframe: Week 13Population: ITT Population
Outcome measures
| Measure |
5 mg Before Breakfast
n=280 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=275 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=277 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population
|
-42.331 Percent Change
Interval -45.643 to -39.019
|
-46.781 Percent Change
Interval -50.127 to -43.436
|
-46.054 Percent Change
Interval -49.386 to -42.723
|
SECONDARY outcome
Timeframe: Week 26Population: ITT Population.
Outcome measures
| Measure |
5 mg Before Breakfast
n=274 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=265 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=273 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population
|
-44.386 Percent Change
Interval -47.882 to -40.889
|
-49.183 Percent Change
Interval -52.743 to -45.623
|
-49.358 Percent Change
Interval -52.863 to -45.852
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population
Outcome measures
| Measure |
5 mg Before Breakfast
n=258 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=256 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=258 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population
|
-44.410 Percent Change
Interval -48.14 to -40.68
|
-49.185 Percent Change
Interval -52.931 to -45.44
|
-50.048 Percent Change
Interval -53.78 to -46.316
|
SECONDARY outcome
Timeframe: Week 52 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 52.
Outcome measures
| Measure |
5 mg Before Breakfast
n=281 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=275 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=279 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population
|
-42.172 Percent Change
Interval -45.959 to -38.385
|
-48.724 Percent Change
Interval -52.556 to -44.892
|
-47.703 Percent Change
Interval -51.506 to -43.901
|
SECONDARY outcome
Timeframe: Week 104Population: ITT Population.
Outcome measures
| Measure |
5 mg Before Breakfast
n=245 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=235 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=238 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population
|
-44.155 Percent Change
Interval -48.803 to -39.506
|
-51.985 Percent Change
Interval -56.737 to -47.232
|
-52.538 Percent Change
Interval -57.257 to -47.818
|
SECONDARY outcome
Timeframe: Week 104 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 104.
Outcome measures
| Measure |
5 mg Before Breakfast
n=281 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=275 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=279 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population
|
-41.451 Percent Change
Interval -45.96 to -36.942
|
-49.253 Percent Change
Interval -53.815 to -44.691
|
-48.752 Percent Change
Interval -53.279 to -44.224
|
SECONDARY outcome
Timeframe: Week 13Population: ITT Population.
Outcome measures
| Measure |
5 mg Before Breakfast
n=280 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=275 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=277 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population
|
-23.386 Percent Change
Interval -25.425 to -21.347
|
-25.141 Percent Change
Interval -27.201 to -23.082
|
-25.191 Percent Change
Interval -27.243 to -23.14
|
SECONDARY outcome
Timeframe: Week 26Population: ITT Population.
Outcome measures
| Measure |
5 mg Before Breakfast
n=274 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=265 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=273 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population
|
-31.273 Percent Change
Interval -33.311 to -29.236
|
-33.680 Percent Change
Interval -35.755 to -31.606
|
-32.582 Percent Change
Interval -34.625 to -30.54
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population.
Outcome measures
| Measure |
5 mg Before Breakfast
n=258 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=256 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=258 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population
|
-31.895 Percent Change
Interval -34.132 to -29.658
|
-33.450 Percent Change
Interval -35.696 to -31.204
|
-33.507 Percent Change
Interval -35.745 to -31.269
|
SECONDARY outcome
Timeframe: Week 52 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 52.
Outcome measures
| Measure |
5 mg Before Breakfast
n=281 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=275 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=279 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population
|
-31.367 Percent Change
Interval -33.536 to -29.199
|
-32.802 Percent Change
Interval -34.996 to -30.607
|
-32.829 Percent Change
Interval -35.007 to -30.652
|
SECONDARY outcome
Timeframe: Week 104Population: ITT Population.
Outcome measures
| Measure |
5 mg Before Breakfast
n=245 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=235 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=238 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population
|
-33.394 Percent Change
Interval -35.969 to -30.819
|
-36.143 Percent Change
Interval -38.776 to -33.51
|
-36.810 Percent Change
Interval -39.424 to -34.195
|
SECONDARY outcome
Timeframe: Week 104 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 104.
Outcome measures
| Measure |
5 mg Before Breakfast
n=281 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=275 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=279 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population
|
-32.572 Percent Change
Interval -35.042 to -30.103
|
-34.769 Percent Change
Interval -37.268 to -32.271
|
-34.824 Percent Change
Interval -37.303 to -32.344
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population
Outcome measures
| Measure |
5 mg Before Breakfast
n=257 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=257 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=257 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Number of Patients With at Least One New Fractured Vertebra, Week 52
|
2 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 52 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 52.
Outcome measures
| Measure |
5 mg Before Breakfast
n=270 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=261 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=271 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population
|
2 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 104Population: ITT Population.
Outcome measures
| Measure |
5 mg Before Breakfast
n=244 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=233 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=237 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population
|
5 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 104 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 104.
Outcome measures
| Measure |
5 mg Before Breakfast
n=274 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=265 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=273 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population
|
5 Participants
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population
Outcome measures
| Measure |
5 mg Before Breakfast
n=257 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=257 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=257 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Number of Patients With No New Fractured Vertebra, Week 52
|
255 Participants
|
255 Participants
|
254 Participants
|
SECONDARY outcome
Timeframe: Week 52 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 52.
Outcome measures
| Measure |
5 mg Before Breakfast
n=270 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=261 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=271 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint
|
268 Participants
|
259 Participants
|
268 Participants
|
SECONDARY outcome
Timeframe: Week 104Population: ITT Population
Outcome measures
| Measure |
5 mg Before Breakfast
n=244 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=233 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=237 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Number of Patients With No New Fractured Vertebra, Week 104
|
239 Participants
|
231 Participants
|
233 Participants
|
SECONDARY outcome
Timeframe: Week 104 / EndpointPopulation: ITT Population. Last Observation Carried Forward at Week 104.
Outcome measures
| Measure |
5 mg Before Breakfast
n=274 Participants
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=265 Participants
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=273 Participants
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint
|
269 Participants
|
263 Participants
|
267 Participants
|
Adverse Events
5 mg Before Breakfast
Serious events: 31 serious events
Other events: 243 other events
Deaths: 0 deaths
35 mg After Breakfast
Serious events: 32 serious events
Other events: 250 other events
Deaths: 0 deaths
35 mg Before Breakfast
Serious events: 32 serious events
Other events: 264 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 mg Before Breakfast
n=307 participants at risk
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=307 participants at risk
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=308 participants at risk
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Eye disorders
Macular Degeneration
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Humerous Fracture
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Vascular disorders
Hypertension
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Cardiac disorders
Hypertensive Heart Disease
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Joint Instability
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Endocrine disorders
Antidiuretic Hormone Abnormality
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Psychiatric disorders
Anxiety Disorder due to General Medical Condition
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Bacterial Infection
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Breast Neoplasm
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Adrenal Gland
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Investigations
Body Mass Index Decreased
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Reproductive system and breast disorders
Breast Dysplasia
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Cardiac disorders
Cardiac Arrest
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Cardiac disorders
Carotid Artery Stenosis
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Cholecystitis Infective
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Chondrolysis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/308 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Investigations
Cystoscopy Abnormal
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Ear and labyrinth disorders
Deafness Unilateral
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
General disorders
Device Dislocation
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Diverticulitis
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Investigations
ECG Signs of Myocardial Ischaemia
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Psychiatric disorders
Emotional Disorder
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
General disorders
Exercise Tolerance Decreased
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Reproductive system and breast disorders
Female Genital Tract Fistula
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Nervous system disorders
Guillain-Barre Syndrome
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Renal and urinary disorders
Haematuria
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Mengitis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Oedematous Pancreatitis
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Skin and subcutaneous tissue disorders
Parapsoriasis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Nervous system disorders
Parkinson's Disease
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.98%
3/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Microemboli
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Sinuitis
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Renal and urinary disorders
Stress Urinary Incontinence
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Cardiac disorders
Superventricular Tachycardia
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Therapeutic Agent Toxicity
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Renal and urinary disorders
Urinary Bladder Polyp
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Reproductive system and breast disorders
Vaginal Prolapse
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Vascular disorders
Varicose Vein
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
Other adverse events
| Measure |
5 mg Before Breakfast
n=307 participants at risk
5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
|
35 mg After Breakfast
n=307 participants at risk
35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
|
35 mg Before Breakfast
n=308 participants at risk
35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
4.2%
13/307 • Number of events 14 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
5.5%
17/307 • Number of events 18 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
4.5%
14/308 • Number of events 16 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Cardiac disorders
Palpitations
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Nervous system disorders
Paraesthesia
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Periodontitis
|
1.6%
5/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.97%
3/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Pharyngitis
|
2.3%
7/307 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
3.6%
11/307 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
3.9%
12/308 • Number of events 16 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Pneumonia
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.0%
6/307 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
1.3%
4/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.0%
6/307 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.6%
8/308 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.65%
2/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
General disorders
Oedema Peripheral
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.0%
6/307 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.9%
6/308 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.97%
3/308 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.3%
10/307 • Number of events 10 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.6%
8/307 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
General disorders
Pain
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.9%
6/308 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Abdominal Distension
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/308 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.3%
10/307 • Number of events 11 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
6.2%
19/307 • Number of events 21 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
6.5%
20/308 • Number of events 23 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.0%
6/307 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.6%
8/307 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
3.6%
11/307 • Number of events 15 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
8.4%
26/308 • Number of events 37 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/308 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.6%
8/307 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.97%
3/308 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Psychiatric disorders
Anxiety
|
1.6%
5/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Cardiac disorders
Arrhythmia
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.7%
33/307 • Number of events 38 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
9.4%
29/307 • Number of events 39 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
8.8%
27/308 • Number of events 33 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.97%
3/308 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
General disorders
Asthenia
|
2.0%
6/307 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.6%
5/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.8%
27/307 • Number of events 31 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
9.4%
29/307 • Number of events 36 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
9.4%
29/308 • Number of events 31 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Investigations
Blood Parathyroid Hormone Increased
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.3%
7/308 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Investigations
Blood Pressure Increased
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.9%
6/308 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Bronchitis
|
6.5%
20/307 • Number of events 26 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
5.5%
17/307 • Number of events 25 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
6.8%
21/308 • Number of events 24 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Eye disorders
Cataract
|
2.3%
7/307 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.9%
6/308 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
General disorders
Chest Pain
|
1.6%
5/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/308 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Hepatobiliary disorders
Cholethiasis
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Eye disorders
Conjunctivitis
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Constipation
|
3.6%
11/307 • Number of events 13 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
5.5%
17/307 • Number of events 17 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
5.5%
17/308 • Number of events 17 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.6%
14/307 • Number of events 15 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
3.6%
11/307 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.6%
8/308 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
10/307 • Number of events 11 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.9%
9/307 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.9%
6/308 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Cystitis
|
3.9%
12/307 • Number of events 13 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.9%
9/307 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.9%
6/308 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Dental Caries
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Psychiatric disorders
Depression
|
1.6%
5/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.0%
6/307 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.3%
7/308 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/307 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.3%
7/308 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
19/307 • Number of events 25 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
9.8%
30/307 • Number of events 32 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
6.8%
21/308 • Number of events 24 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Diverticulitis
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.97%
3/308 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/308 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Nervous system disorders
Dizziness
|
3.3%
10/307 • Number of events 10 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
3.3%
10/307 • Number of events 10 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
3.6%
11/308 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
General disorders
Drug Intolerance
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.9%
6/308 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.2%
16/307 • Number of events 19 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
5.9%
18/307 • Number of events 24 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
3.9%
12/308 • Number of events 15 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Fall
|
5.2%
16/307 • Number of events 18 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
5.9%
18/307 • Number of events 20 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
3.6%
11/308 • Number of events 11 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
General disorders
Fatigue
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.3%
7/307 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
5/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
6/307 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Gastroenteritis
|
2.3%
7/307 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.9%
9/307 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
3.2%
10/308 • Number of events 10 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 10 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Gastrointestinal Viral Infection
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
2.9%
9/307 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
3.6%
11/308 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Gingivitis
|
0.65%
2/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/307 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.97%
3/308 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Vascular disorders
Haematoma
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.3%
7/307 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Nervous system disorders
Headache
|
5.9%
18/307 • Number of events 18 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.9%
9/307 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
4.5%
14/308 • Number of events 14 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Herpes Zoster
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.6%
8/307 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.97%
3/308 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
1.3%
4/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
3.2%
10/308 • Number of events 10 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/308 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
1.6%
5/307 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/308 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.0%
6/307 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
4.2%
13/307 • Number of events 13 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.9%
9/308 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Endocrine disorders
Hyperparathyroidism
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Endocrine disorders
Hyperparathyroidism Secondary
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/308 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Immune system disorders
Hypersensitivity
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Vascular disorders
Hypertension
|
6.5%
20/307 • Number of events 23 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
6.5%
20/307 • Number of events 20 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
6.8%
21/308 • Number of events 22 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Endocrine disorders
Hypoparathyroidism
|
1.6%
5/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Influenza
|
7.5%
23/307 • Number of events 28 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
8.8%
27/307 • Number of events 33 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
8.1%
25/308 • Number of events 29 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
General disorders
Influenza Like Illness
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Psychiatric disorders
Insomnia
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Nervous system disorders
Memory Impairment
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.00%
0/308 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.9%
9/307 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
3.9%
12/308 • Number of events 16 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
4.2%
13/307 • Number of events 13 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
4.2%
13/307 • Number of events 14 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
3.6%
11/308 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.98%
3/307 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
24/307 • Number of events 29 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
10.4%
32/307 • Number of events 38 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
12.3%
38/308 • Number of events 48 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Nausea
|
4.9%
15/307 • Number of events 17 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
3.9%
12/307 • Number of events 15 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
4.5%
14/308 • Number of events 16 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
General disorders
Pyrexia
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/308 • Number of events 10 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.9%
6/308 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/308 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Rhinitis
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/307 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Nervous system disorders
Sciatica
|
2.3%
7/307 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.6%
5/307 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.65%
2/308 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Sinusitis
|
2.6%
8/307 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.97%
3/308 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Psychiatric disorders
Sleep Disorder
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.00%
0/307 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.0%
6/307 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.6%
8/307 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.97%
3/308 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Tooth Infection
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.9%
9/307 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
4.2%
13/307 • Number of events 13 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
3.9%
12/308 • Number of events 17 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Urinary Tract Infection
|
6.5%
20/307 • Number of events 21 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
6.8%
21/307 • Number of events 27 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
7.1%
22/308 • Number of events 29 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Vascular disorders
Varicose Vein
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.33%
1/307 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/308 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Ear and labyrinth disorders
Vertigo
|
2.3%
7/307 • Number of events 10 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.3%
7/307 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.97%
3/308 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Infections and infestations
Viral Infection
|
0.65%
2/307 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
1.3%
4/307 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
0.97%
3/308 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
10/307 • Number of events 10 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
4.9%
15/307 • Number of events 18 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
2.6%
8/308 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
|
Additional Information
Grexan Wulff, Manager Regulatory Affairs
Warner Chilcott
Phone: 973-442-3376
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The findings of the study may be published in a scientific journal or presented at a scientific meeting. Before submitting the results of the study for publication or presentation, the Investigator will allow the sponsor 30 days in which to review and comment on the manuscript.
- Publication restrictions are in place
Restriction type: OTHER