Trial Outcomes & Findings for MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis (NCT NCT00048061)
NCT ID: NCT00048061
Last Updated: 2018-03-29
Results Overview
Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1609 participants
Primary outcome timeframe
From Baseline (Month 0) to Month 12
Results posted on
2018-03-29
Participant Flow
The study was conducted from 26 April 2002 to 08 Dec 2004 across 65 centers in the world.
A total of 1609 participants were randomized, of which 1602 received the study drug.
Participant milestones
| Measure |
Ibandronate 2.5 mg
Participants received 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 international units (IU) per day.
|
Ibandronate 50/50 mg
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
400
|
401
|
400
|
401
|
|
Overall Study
COMPLETED
|
325
|
328
|
316
|
322
|
|
Overall Study
NOT COMPLETED
|
75
|
73
|
84
|
79
|
Reasons for withdrawal
| Measure |
Ibandronate 2.5 mg
Participants received 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 international units (IU) per day.
|
Ibandronate 50/50 mg
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
41
|
32
|
44
|
37
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
20
|
29
|
29
|
32
|
|
Overall Study
Did not follow-up
|
5
|
5
|
4
|
5
|
|
Overall Study
Early improvement
|
6
|
5
|
3
|
0
|
Baseline Characteristics
MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
Baseline characteristics by cohort
| Measure |
Ibandronate 2.5 mg
n=395 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=396 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=396 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=396 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Total
n=1583 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 6.61 • n=5 Participants
|
66.0 years
STANDARD_DEVIATION 6.71 • n=7 Participants
|
66.2 years
STANDARD_DEVIATION 6.38 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 6.64 • n=4 Participants
|
66.0 years
STANDARD_DEVIATION 6.58 • n=21 Participants
|
|
Sex: Female, Male
Female
|
395 Participants
n=5 Participants
|
396 Participants
n=7 Participants
|
396 Participants
n=5 Participants
|
396 Participants
n=4 Participants
|
1583 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Month 0) to Month 12Population: The per-protocol(PP) population included participants in Intent-to-treat(ITT) population who were randomized, received at least one dose of medication and had at least one valid efficacy(BMD or Serum CTX)follow-up data point;defined as any measurement that can be scientifically compared to baseline measurement, and had no major protocol violations.
Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=314 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=322 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=306 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=314 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density
|
3.7427 Percent change
Standard Deviation 4.0149
|
4.3395 Percent change
Standard Deviation 3.9557
|
4.0328 Percent change
Standard Deviation 3.6815
|
4.7611 Percent change
Standard Deviation 3.8931
|
SECONDARY outcome
Timeframe: From Baseline (Month 0) to Month 24Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol.Participants available at particular time point for assessment were included in the analysis.
Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24.
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=294 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=294 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=278 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=291 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
|
4.9623 Percent change
Standard Deviation 4.6525
|
5.3350 Percent change
Standard Deviation 4.8235
|
5.5760 Percent change
Standard Deviation 4.2280
|
6.5503 Percent change
Standard Deviation 4.5118
|
SECONDARY outcome
Timeframe: From Baseline (Month 0) to Months 12 and 24Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
The absolute change (g/cm\^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated.
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=314 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=322 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=306 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=314 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
At 24 months, n = 294, 294, 278, 291
|
0.036 g/cm2
Standard Deviation 0.0337
|
0.039 g/cm2
Standard Deviation 0.0355
|
0.042 g/cm2
Standard Deviation 0.0313
|
0.049 g/cm2
Standard Deviation 0.0330
|
|
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
At 12 months, n = 314, 322, 306, 314
|
0.028 g/cm2
Standard Deviation 0.0291
|
0.033 g/cm2
Standard Deviation 0.0298
|
0.030 g/cm2
Standard Deviation 0.0271
|
0.036 g/cm2
Standard Deviation 0.0290
|
SECONDARY outcome
Timeframe: From Baseline (Month 0) to Months 12 and 24Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center.
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=315 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=319 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=306 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=316 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
Total hip At Month 12, n = 315,319,306,316
|
1.9626 Percent change
Standard Deviation 2.8311
|
2.2172 Percent change
Standard Deviation 2.7504
|
2.6878 Percent change
Standard Deviation 2.6646
|
3.0092 Percent change
Standard Deviation 2.7105
|
|
Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
Total hip At Month 24, n = 292,291,277,289
|
2.4955 Percent change
Standard Deviation 3.0884
|
2.8132 Percent change
Standard Deviation 3.2408
|
3.5165 Percent change
Standard Deviation 3.2831
|
4.1601 Percent change
Standard Deviation 2.8335
|
|
Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
Trochanter At Month 12, n = 315,319,306,316
|
3.1917 Percent change
Standard Deviation 4.1268
|
3.4931 Percent change
Standard Deviation 4.0876
|
3.8226 Percent change
Standard Deviation 3.7077
|
4.5904 Percent change
Standard Deviation 3.9436
|
|
Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
Trochanter At Month 24, n = 292,291,277,289
|
4.0204 Percent change
Standard Deviation 4.3460
|
4.6289 Percent change
Standard Deviation 4.5518
|
5.3135 Percent change
Standard Deviation 4.7335
|
6.1755 Percent change
Standard Deviation 4.2550
|
|
Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
Femoral neck At Month 12, n = 315,319,306,316
|
1.7164 Percent change
Standard Deviation 3.6233
|
1.8141 Percent change
Standard Deviation 3.4391
|
1.8797 Percent change
Standard Deviation 3.4998
|
2.1914 Percent change
Standard Deviation 3.4842
|
|
Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
Femoral neck At Month 24, n=292,291,277,289
|
1.9087 Percent change
Standard Deviation 4.2212
|
2.0581 Percent change
Standard Deviation 4.1189
|
2.6209 Percent change
Standard Deviation 3.8339
|
3.1195 Percent change
Standard Deviation 4.0549
|
SECONDARY outcome
Timeframe: From Baseline (Month 0) to Months 12 and 24Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=315 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=319 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=306 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=316 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
Total hip At Month 12, n = 315,319,306,316
|
0.014 g/cm2
Standard Deviation 0.0204
|
0.016 g/cm2
Standard Deviation 0.0205
|
0.020 g/cm2
Standard Deviation 0.0190
|
0.022 g/cm2
Standard Deviation 0.0190
|
|
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
Total hip At Month 24, n = 292,291,277,290
|
0.018 g/cm2
Standard Deviation 0.0225
|
0.021 g/cm2
Standard Deviation 0.0241
|
0.026 g/cm2
Standard Deviation 0.0237
|
0.031 g/cm2
Standard Deviation 0.0199
|
|
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
Trochanter At Month 12, n = 315,319,306,316
|
0.018 g/cm2
Standard Deviation 0.0228
|
0.020 g/cm2
Standard Deviation 0.0238
|
0.022 g/cm2
Standard Deviation 0.0206
|
0.026 g/cm2
Standard Deviation 0.0211
|
|
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
Trochanter At Month 24, n = 292,291,277,290
|
0.023 g/cm2
Standard Deviation 0.0241
|
0.027 g/cm2
Standard Deviation 0.0259
|
0.030 g/cm2
Standard Deviation 0.0263
|
0.035 g/cm2
Standard Deviation 0.0231
|
|
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
Femoral neck At Month 12, n = 315,319,306,316
|
0.011 g/cm2
Standard Deviation 0.0230
|
0.011 g/cm2
Standard Deviation 0.0226
|
0.012 g/cm2
Standard Deviation 0.0228
|
0.014 g/cm2
Standard Deviation 0.0224
|
|
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
Femoral neck At Month 24, n = 315,319,306,316
|
0.012 g/cm2
Standard Deviation 0.0265
|
0.013 g/cm2
Standard Deviation 0.0272
|
0.017 g/cm2
Standard Deviation 0.0248
|
0.020 g/cm2
Standard Deviation 0.0257
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline.
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=314 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=322 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=306 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=314 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24
At Month 12, n = 314,322,306,314
|
83.8 Percentage of participants
|
87.6 Percentage of participants
|
86.6 Percentage of participants
|
90.8 Percentage of participants
|
|
Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24
At Month 24, n = 294,294,278,291
|
86.4 Percentage of participants
|
87.8 Percentage of participants
|
87.8 Percentage of participants
|
93.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=315 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=319 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=306 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=306 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24
At Month 12, n = 315,319,306,306
|
76.8 Percentage of participants
|
81.2 Percentage of participants
|
86.9 Percentage of participants
|
90.5 Percentage of participants
|
|
Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24
At Month 24, n = 292,291,277,289
|
78.4 Percentage of participants
|
83.2 Percentage of participants
|
88.8 Percentage of participants
|
93.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=315 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=319 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=306 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=316 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24
At Month 12, n = 315,319,306,316
|
80.0 Percentage of participants
|
83.1 Percentage of participants
|
88.2 Percentage of participants
|
92.4 Percentage of participants
|
|
Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24
At Month 24, n = 292,291,277,289
|
84.2 Percentage of participants
|
86.6 Percentage of participants
|
89.9 Percentage of participants
|
94.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=315 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=319 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=306 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=316 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24
At Month 12, n = 315,319,306,316
|
71.1 Percentage of participants
|
72.4 Percentage of participants
|
69.0 Percentage of participants
|
75.3 Percentage of participants
|
|
Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24
At Month 24, n = 292,291,277,289
|
69.2 Percentage of participants
|
71.1 Percentage of participants
|
78.7 Percentage of participants
|
81.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=314 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=318 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=304 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=310 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
At Month 12, n = 314,318,304,310
|
65.6 Percentage of participants
|
72.3 Percentage of participants
|
77.6 Percentage of participants
|
83.5 Percentage of participants
|
|
Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
At Month 24, n = 292,291,276,287
|
70.5 Percentage of participants
|
75.3 Percentage of participants
|
79.3 Percentage of participants
|
87.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=314 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=318 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=304 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=310 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
At Month 12, n = 314,318,304,310
|
68.8 Percentage of participants
|
75.5 Percentage of participants
|
78.0 Percentage of participants
|
84.2 Percentage of participants
|
|
Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
At Month 24, n = 292,291,276,287
|
75.7 Percentage of participants
|
77.3 Percentage of participants
|
80.1 Percentage of participants
|
88.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=314 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=318 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=304 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=310 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
At Month 12, n = 314,318,304,310
|
62.4 Percentage of participants
|
64.5 Percentage of participants
|
60.9 Percentage of participants
|
68.7 Percentage of participants
|
|
Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
At Month 24, n = 292,291,276,287
|
63.4 Percentage of participants
|
63.9 Percentage of participants
|
71.0 Percentage of participants
|
75.6 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Month 0) to Months 3, 6, 12, 24Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=272 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=278 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=276 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=278 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24
At Month 3, n = 269,278,271,276
|
-49.5458 Percent change
Standard Deviation 30.8286
|
-46.4771 Percent change
Standard Deviation 26.5096
|
-50.2368 Percent change
Standard Deviation 28.1576
|
-57.3433 Percent change
Standard Deviation 33.9505
|
|
Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24
At Month 6, n = 270,272,274,278
|
55.5900 Percent change
Standard Deviation 34.1672
|
-53.9838 Percent change
Standard Deviation 27.3557
|
-55.9614 Percent change
Standard Deviation 31.2801
|
-66.4354 Percent change
Standard Deviation 25.4762
|
|
Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24
At Month 12, n = 272,276,276,267
|
-58.8244 Percent change
Standard Deviation 29.8250
|
-57.5363 Percent change
Standard Deviation 27.2271
|
-58.1046 Percent change
Standard Deviation 33.5095
|
-67.0703 Percent change
Standard Deviation 41.4563
|
|
Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24
At Month 24, n = 221,215,211,235
|
-51.2360 Percent change
Standard Deviation 37.9032
|
-51.3040 Percent change
Standard Deviation 27.9844
|
-49.5567 Percent change
Standard Deviation 44.9707
|
61.8822 Percent change
Standard Deviation 28.2309
|
SECONDARY outcome
Timeframe: From Baseline (Month 0) to Months 12 and 24Population: The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=272 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=276 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=276 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=267 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Absolute Change In Baseline in Serum CTX to Months 12 and 24
Month 12, n = 272, 276, 276, 267
|
-0.323 ng/ml
Standard Deviation 0.2292
|
-0.326 ng/ml
Standard Deviation 0.2212
|
-0.340 ng/ml
Standard Deviation 0.2287
|
-0.377 ng/ml
Standard Deviation 0.2135
|
|
Absolute Change In Baseline in Serum CTX to Months 12 and 24
Month 24, n = 221, 215, 211, 235
|
-0.285 ng/ml
Standard Deviation 0.2052
|
-0.298 ng/ml
Standard Deviation 0.1980
|
-0.312 ng/ml
Standard Deviation 0.2398
|
-0.340 ng/ml
Standard Deviation 0.2062
|
SECONDARY outcome
Timeframe: Up to Month 24Population: The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point.
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=395 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=396 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=396 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=396 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Number of Participants With Any Adverse Events and Serious Adverse Event
Any AE
|
302 Participants
|
313 Participants
|
318 Participants
|
317 Participants
|
|
Number of Participants With Any Adverse Events and Serious Adverse Event
SAE
|
38 Participants
|
54 Participants
|
55 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Up to Month 24Population: The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point. n = number of participants evaluable at particular time of assessment.
Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter \[g/L\]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10\*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter \[mmol/L\]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter \[umol/L\].
Outcome measures
| Measure |
Ibandronate 2.5 mg
n=390 Participants
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=390 Participants
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=385 Participants
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=385 Participants
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Number Of Participants With Marked Laboratory Abnormalities
Hematocrit Low, n = 389,387,382,385
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number Of Participants With Marked Laboratory Abnormalities
Hemoglobin High, n = 389,389,382,385
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number Of Participants With Marked Laboratory Abnormalities
Hemoglobin Low, n = 389,389,382,385
|
3 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Number Of Participants With Marked Laboratory Abnormalities
WBC Low, n = 389,389,382,385
|
1 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Number Of Participants With Marked Laboratory Abnormalities
ALT (SGPT) High, n = 390,390,385,385
|
9 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
|
Number Of Participants With Marked Laboratory Abnormalities
BUN High, n = 390,390,385,385
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number Of Participants With Marked Laboratory Abnormalities
Creatinine High, n = 390,390,385,385
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number Of Participants With Marked Laboratory Abnormalities
Chloride Low, n =3 89,390,385,384
|
3 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number Of Participants With Marked Laboratory Abnormalities
Potassium Low, n = 389,390,385,383
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number Of Participants With Marked Laboratory Abnormalities
Sodium High, n = 389,390,385,384
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number Of Participants With Marked Laboratory Abnormalities
Sodium Low, n = 389,390,385,384
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number Of Participants With Marked Laboratory Abnormalities
Calcium High, n = 390,390,385,385
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number Of Participants With Marked Laboratory Abnormalities
Phosphate High, n = 390,390,385,385
|
4 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number Of Participants With Marked Laboratory Abnormalities
Phosphate Low, n = 390,390,385,385
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
Ibandronate 2.5 mg
Serious events: 38 serious events
Other events: 190 other events
Deaths: 0 deaths
Ibandronate 50/50 mg
Serious events: 54 serious events
Other events: 190 other events
Deaths: 0 deaths
Ibandronate 100 mg
Serious events: 55 serious events
Other events: 191 other events
Deaths: 0 deaths
Ibandronate 150 mg
Serious events: 45 serious events
Other events: 182 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibandronate 2.5 mg
n=395 participants at risk
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=396 participants at risk
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=396 participants at risk
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=396 participants at risk
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Chronic sinusitis
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Dacryocystitis infective
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Pneumonia
|
0.76%
3/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.51%
2/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.51%
2/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Cellulitis
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Lower respiratory tract Infection
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Ear infection
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Ear infection viral
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Gangrene
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Hematoma infection
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Laryngopharyngitis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Postoperative abscess
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Superinfection
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Superinfection lung
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Urosepsis
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Melaena
|
0.51%
2/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Gastrointestinal haemorrhage
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Cardiac failure
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.76%
3/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Myocardial ischemia
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.51%
2/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.51%
2/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Atrial fibrillation
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.51%
2/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Coronary artery disease
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Myocardial infarction
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.51%
2/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.51%
2/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Cardiac pacemaker malfunction
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Pain trauma activated
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gammopathy
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Syncope
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.51%
2/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Dementia alzheimer's type
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Embolic stroke
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Loss of consciousness
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Musculoskeletal and connective tissue disorders
Localised osteoarthritis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
1.0%
4/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.51%
2/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Nervous system disorders
Back pain
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Musculoskeletal and connective tissue disorders
Spondylosis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Musculoskeletal and connective tissue disorders
Toe deformity
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Vascular disorders
Hypertension
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.51%
2/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Vascular disorders
Haematoma
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Vascular disorders
Hypotension
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Psychiatric disorders
Depression
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.51%
2/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.51%
2/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Psychiatric disorders
Anxiety
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Psychiatric disorders
Bipolar disorder
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.51%
2/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal polyp
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Renal and urinary disorders
Cystocele
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Renal and urinary disorders
Urethral syndrome
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Reproductive system and breast disorders
Endometrial hypertrophy
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
General disorders
Chest pain
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.51%
2/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
General disorders
Pyrexia
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Eye disorders
Cataract
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Eye disorders
Diplopia
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Eye disorders
Macular hole
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Surgical and medical procedures
Cyst removal
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Surgical and medical procedures
Eventration procedure
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Congenital, familial and genetic disorders
Dermoid cyst of ovary
|
0.25%
1/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Ear and labyrinth disorders
Vestibular neuronitis
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.25%
1/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
0.00%
0/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
Other adverse events
| Measure |
Ibandronate 2.5 mg
n=395 participants at risk
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 50/50 mg
n=396 participants at risk
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 100 mg
n=396 participants at risk
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
Ibandronate 150 mg
n=396 participants at risk
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
24/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
9.8%
39/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
8.8%
35/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
6.8%
27/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
25/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
9.1%
36/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
9.1%
36/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
7.1%
28/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
9/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
3.5%
14/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
3.3%
13/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
5.1%
20/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Musculoskeletal and connective tissue disorders
Localised osteoarthritis
|
2.5%
10/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
3.0%
12/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
3.0%
12/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
4.8%
19/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Nasopharyngitis
|
9.6%
38/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
5.8%
23/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
6.8%
27/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
6.1%
24/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Influenza
|
6.3%
25/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
7.8%
31/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
4.5%
18/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
6.6%
26/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
15/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
4.5%
18/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
3.8%
15/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
4.8%
19/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Bronchitis
|
5.1%
20/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
2.5%
10/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
4.5%
18/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
3.0%
12/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
20/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
4.8%
19/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
4.5%
18/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
6.3%
25/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
21/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
5.1%
20/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
4.0%
16/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
4.8%
19/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
28/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
7.3%
29/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
9.3%
37/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
6.6%
26/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Vascular disorders
Hypertension
|
11.6%
46/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
10.9%
43/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
11.9%
47/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
10.4%
41/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.3%
21/395 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
2.3%
9/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
4.0%
16/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
4.5%
18/396 • 24 months
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER