Trial Outcomes & Findings for A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis. (NCT NCT05338086)
NCT ID: NCT05338086
Last Updated: 2025-03-21
Results Overview
To demonstrate equivalent efficacy of MB09 to EU Prolia in postmenopausal women with osteoporosis in terms of lumbar spine BMD at Week 52 (Month 12). The main analysis method was on the mFAS using a mixed model for repeated measures (MMRM) fitted to the composite %CfB lumbar spine BMD at Month 6 and Month 12, without any imputation of missing data. Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA) and assessments of the lumbar spine (L1 to L4) were performed at a central imaging vendor.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
558 participants
Primary outcome timeframe
Baseline (Screening), up to Week 52
Results posted on
2025-03-21
Participant Flow
A total of 62 sites in 8 countries (Bulgaria, Estonia, Georgia, Hungary, Latvia, Poland, Serbia, and Mexico) screened at least one subject and 56 sites randomised at least one subject into the study.
The study included the Screening Period (28 days before randomization) that began after the participants had signed the written informed consent form. On Day 1 of the Main Treatment Period (MTP), subjects were randomly assigned in a 2:1:1 ratio to one of the 3 arms to receive one subcutaneous (SC) injection of European Union (EU) Prolia or MB09. Only those subjects who tolerated the initial 2 doses received the third dose and proceeded to the Transition/Safety Follow-up Period (TP).
Participant milestones
| Measure |
EU-Prolia (MTP)
* Subjects randomised into Prolia-Prolia group received one SC injection of EU-Prolia® (60 mg/mL) every 6 months (on Day 1, and Month 6).
* EU-Prolia®: 60 mg/mL solution for injection in PFS.
* Daily supplementation: at least 1000 mg elemental calcium and at least 400 IU of vitamin D.
|
MB09-MB09 (TP)
* Subjects randomised into MB09-MB09 group received one subcutaneous (SC) injection of MB09 (60 mg/mL) every 6 months (on Day 1, Month 6, and Month 12).
* MB09 (denosumab biosimilar): 60 mg/mL solution for injection in Prefilled Syringe (PFS).
* Daily supplementation: at least 1000 mg elemental calcium and at least 400 IU of vitamin D.
|
EU-Prolia-MB09 (TP)
* Subjects randomised into Prolia-MB09 group received one SC injection of EU-Prolia® (60 mg/mL) every 6 months (on Day 1 and at Month 6) and one SC injection of MB09 at Month 12.
* MB09 (denosumab biosimilar) and EU-Prolia®: 60 mg/mL solution for injection in PFS.
* Daily supplementation: at least 1000 mg elemental calcium and at least 400 IU of vitamin D.
|
EU Prolia-EU Prolia (TP)
* Subjects randomised into Prolia-Prolia group received one SC injection of EU-Prolia® (60 mg/mL) every 6 months (on Day 1, Month 6 and Month12).
* EU-Prolia®: 60 mg/mL solution for injection in PFS.
* Daily supplementation: at least 1000 mg elemental calcium and at least 400 IU of vitamin D.
|
MB09 (MTP)
* Subjects randomised into MB09 group received one subcutaneous (SC) injection of MB09 (60 mg/mL) every 6 months (on Day 1, and Month 6).
* MB09 (denosumab biosimilar): 60 mg/mL solution for injection in Prefilled Syringe (PFS).
* Daily supplementation: at least 1000 mg elemental calcium and at least 400 IU of vitamin D.
|
|---|---|---|---|---|---|
|
Main Treatment Period (Day1 to Month 12)
STARTED
|
277
|
0
|
0
|
0
|
281
|
|
Main Treatment Period (Day1 to Month 12)
Safety Analysis Set (SAF)
|
278
|
0
|
0
|
0
|
277
|
|
Main Treatment Period (Day1 to Month 12)
Full Analysis Set (FAS)
|
277
|
0
|
0
|
0
|
278
|
|
Main Treatment Period (Day1 to Month 12)
Modified Full Analysis Set (mFAS)
|
266
|
0
|
0
|
0
|
258
|
|
Main Treatment Period (Day1 to Month 12)
Pharmacokinetics Parameter Set (PKPS)
|
274
|
0
|
0
|
0
|
269
|
|
Main Treatment Period (Day1 to Month 12)
Pharmacokinetics Concentration Set (PKCS)
|
278
|
0
|
0
|
0
|
277
|
|
Main Treatment Period (Day1 to Month 12)
COMPLETED
|
252
|
0
|
0
|
0
|
245
|
|
Main Treatment Period (Day1 to Month 12)
NOT COMPLETED
|
25
|
0
|
0
|
0
|
36
|
|
Transition Period (M12 to M18)
STARTED
|
0
|
245
|
130
|
122
|
0
|
|
Transition Period (M12 to M18)
Safety Analysis Set for Transition Period (SAF-TP).
|
0
|
244
|
130
|
123
|
0
|
|
Transition Period (M12 to M18)
Full Analysis Set for Transition Period (FAS-TP)
|
0
|
245
|
130
|
122
|
0
|
|
Transition Period (M12 to M18)
Modified Full Analysis Set for Transition Period (mFAS-TP)
|
0
|
233
|
127
|
121
|
0
|
|
Transition Period (M12 to M18)
Pharmacokinetic Concentration Set for Transition Period (PKCS-TP)
|
0
|
244
|
130
|
123
|
0
|
|
Transition Period (M12 to M18)
Pharmacokinetic Parameter Set for Transition Period (PKPS-TP)
|
0
|
228
|
126
|
111
|
0
|
|
Transition Period (M12 to M18)
COMPLETED
|
0
|
239
|
127
|
119
|
0
|
|
Transition Period (M12 to M18)
NOT COMPLETED
|
0
|
6
|
3
|
3
|
0
|
Reasons for withdrawal
| Measure |
EU-Prolia (MTP)
* Subjects randomised into Prolia-Prolia group received one SC injection of EU-Prolia® (60 mg/mL) every 6 months (on Day 1, and Month 6).
* EU-Prolia®: 60 mg/mL solution for injection in PFS.
* Daily supplementation: at least 1000 mg elemental calcium and at least 400 IU of vitamin D.
|
MB09-MB09 (TP)
* Subjects randomised into MB09-MB09 group received one subcutaneous (SC) injection of MB09 (60 mg/mL) every 6 months (on Day 1, Month 6, and Month 12).
* MB09 (denosumab biosimilar): 60 mg/mL solution for injection in Prefilled Syringe (PFS).
* Daily supplementation: at least 1000 mg elemental calcium and at least 400 IU of vitamin D.
|
EU-Prolia-MB09 (TP)
* Subjects randomised into Prolia-MB09 group received one SC injection of EU-Prolia® (60 mg/mL) every 6 months (on Day 1 and at Month 6) and one SC injection of MB09 at Month 12.
* MB09 (denosumab biosimilar) and EU-Prolia®: 60 mg/mL solution for injection in PFS.
* Daily supplementation: at least 1000 mg elemental calcium and at least 400 IU of vitamin D.
|
EU Prolia-EU Prolia (TP)
* Subjects randomised into Prolia-Prolia group received one SC injection of EU-Prolia® (60 mg/mL) every 6 months (on Day 1, Month 6 and Month12).
* EU-Prolia®: 60 mg/mL solution for injection in PFS.
* Daily supplementation: at least 1000 mg elemental calcium and at least 400 IU of vitamin D.
|
MB09 (MTP)
* Subjects randomised into MB09 group received one subcutaneous (SC) injection of MB09 (60 mg/mL) every 6 months (on Day 1, and Month 6).
* MB09 (denosumab biosimilar): 60 mg/mL solution for injection in Prefilled Syringe (PFS).
* Daily supplementation: at least 1000 mg elemental calcium and at least 400 IU of vitamin D.
|
|---|---|---|---|---|---|
|
Main Treatment Period (Day1 to Month 12)
Adverse Event
|
0
|
0
|
0
|
0
|
4
|
|
Main Treatment Period (Day1 to Month 12)
Lost to Follow-up
|
2
|
0
|
0
|
0
|
1
|
|
Main Treatment Period (Day1 to Month 12)
Protocol Violation
|
1
|
0
|
0
|
0
|
1
|
|
Main Treatment Period (Day1 to Month 12)
unrelated medical conditions
|
0
|
0
|
0
|
0
|
1
|
|
Main Treatment Period (Day1 to Month 12)
subject dosed in error and did not meet eligibility criteria
|
6
|
0
|
0
|
0
|
6
|
|
Main Treatment Period (Day1 to Month 12)
other
|
16
|
0
|
0
|
0
|
23
|
|
Transition Period (M12 to M18)
Death
|
0
|
1
|
0
|
0
|
0
|
|
Transition Period (M12 to M18)
Withdrawal by Subject
|
0
|
4
|
3
|
2
|
0
|
|
Transition Period (M12 to M18)
Burden of study procedures
|
0
|
1
|
0
|
0
|
0
|
|
Transition Period (M12 to M18)
Subject left the country
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.
Baseline characteristics by cohort
| Measure |
MB09
n=277 Participants
•Subjects randomised into MB09 group received one subcutaneous (SC) injection of MB09 (60 mg/mL) every 6 months (on Day 1, and Month 6).
|
EU-Prolia
n=278 Participants
•Subjects randomised into Prolia-Prolia group received one SC injection of EU-Prolia® (60 mg/mL) every 6 months (on Day 1, and Month 6).
|
Total
n=555 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 6.00 • n=5 Participants
|
65.9 years
STANDARD_DEVIATION 5.90 • n=7 Participants
|
65.8 years
STANDARD_DEVIATION 5.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
277 Participants
n=5 Participants
|
278 Participants
n=7 Participants
|
555 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race - White
|
276 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
551 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race - American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity - Hispanic or Latino
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity - Not Hispanic or Latino
|
267 Participants
n=5 Participants
|
265 Participants
n=7 Participants
|
532 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
24.62 kg/m^2
STANDARD_DEVIATION 3.01 • n=5 Participants
|
24.73 kg/m^2
STANDARD_DEVIATION 3.06 • n=7 Participants
|
24.68 kg/m^2
STANDARD_DEVIATION 3.04 • n=5 Participants
|
|
Osteoporosis diagnosis duration
|
2.6 years
STANDARD_DEVIATION 4.39 • n=5 Participants
|
2.0 years
STANDARD_DEVIATION 3.89 • n=7 Participants
|
2.3 years
STANDARD_DEVIATION 4.15 • n=5 Participants
|
|
Baseline BMD T-score at the lumbar spine
> -3.0 group
|
144 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
287 Participants
n=5 Participants
|
|
Baseline BMD T-score at the lumbar spine
≤ -3.0 group
|
133 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
|
Lumbar spine BMD
|
0.766 g/cm^2
STANDARD_DEVIATION 0.0878 • n=5 Participants
|
0.773 g/cm^2
STANDARD_DEVIATION 0.0862 • n=7 Participants
|
0.770 g/cm^2
STANDARD_DEVIATION 0.0870 • n=5 Participants
|
|
Total hip BMD
|
0.731 g/cm^2
STANDARD_DEVIATION 0.0973 • n=5 Participants
|
0.745 g/cm^2
STANDARD_DEVIATION 0.0946 • n=7 Participants
|
0.738 g/cm^2
STANDARD_DEVIATION 0.0961 • n=5 Participants
|
|
Femur neck BMD
|
0.672 g/cm^2
STANDARD_DEVIATION 0.1085 • n=5 Participants
|
0.685 g/cm^2
STANDARD_DEVIATION 0.1084 • n=7 Participants
|
0.679 g/cm^2
STANDARD_DEVIATION 0.1086 • n=5 Participants
|
|
Prior use of bisphosphonates
Yes
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Prior use of bisphosphonates
No
|
252 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
509 Participants
n=5 Participants
|
|
Previous Fractures in the Medical History
Yes
|
108 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Previous Fractures in the Medical History
No
|
169 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
345 Participants
n=5 Participants
|
|
Menopause duration
|
16.4 years
STANDARD_DEVIATION 7.05 • n=5 Participants
|
16.9 years
STANDARD_DEVIATION 7.35 • n=7 Participants
|
16.7 years
STANDARD_DEVIATION 7.20 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Screening), up to Week 52Population: Modified Full Analysis Set (mFAS) is a subset of subjects in the FAS who met all eligibility criteria. The mFAS term defined a set at the data point level which included a data record at each timepoint for all eligible subjects in the FAS but excluded data observed after the first occurrence of those intercurrent events (ICEs) where a hypothetical strategy was taken (eg, missing a dose, errors or deviations in dosing, or receipt of any prohibited therapies or other osteoporosis medication).
To demonstrate equivalent efficacy of MB09 to EU Prolia in postmenopausal women with osteoporosis in terms of lumbar spine BMD at Week 52 (Month 12). The main analysis method was on the mFAS using a mixed model for repeated measures (MMRM) fitted to the composite %CfB lumbar spine BMD at Month 6 and Month 12, without any imputation of missing data. Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA) and assessments of the lumbar spine (L1 to L4) were performed at a central imaging vendor.
Outcome measures
| Measure |
MB09
n=233 Participants
A total of 2 subcutaneous administration of 60 mg MB09 (proposed denosumab biosimilar) on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
EU-Prolia
n=250 Participants
A total of 2 subcutaneous administration of 60 mg Prolia on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
Throughout the Study: MB09-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for MB09-MB09 group.
|
Throughout the Study: Prolia-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-MB09 group.
|
Throughout the Study: Prolia-Prolia
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-Prolia group.
|
|---|---|---|---|---|---|
|
Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (LS-BMD) at 52 Weeks - Modified Full Analysis Set (mFAS)
|
5.86 Percentage change (%)
Standard Error 0.26
|
5.66 Percentage change (%)
Standard Error 0.25
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening), up to Week 52Population: The Full Analysis Set (FAS) consisted of all consenting randomised subjects who received at least one dose of study treatment.
Difference in means (MB09-Prolia) in the %CfB in lumbar spine BMD after 12 months in postmenopausal women with osteoporosis treated with SC denosumab injections every 6 months. This included all subjects and data records irrespective of failed eligibility criteria, receipt of prohibited medications, discontinued treatment for any reason, had errors or deviations in dosing, or receipt of both doses. Estimation was via Multiple Imputation (MI) and ANCOVA on the FAS. Since the retrieved dropout rate was low, a treatment-failure (TF) penalty was applied to the imputed values at Month 12 for those subjects who received only one dose of the study treatment to centre the distribution of each subject's %CfB values around their baseline level. Bone density measurements were performed by DXA. All DXA scans were submitted to a central imaging vendor for analysis.
Outcome measures
| Measure |
MB09
n=278 Participants
A total of 2 subcutaneous administration of 60 mg MB09 (proposed denosumab biosimilar) on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
EU-Prolia
n=277 Participants
A total of 2 subcutaneous administration of 60 mg Prolia on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
Throughout the Study: MB09-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for MB09-MB09 group.
|
Throughout the Study: Prolia-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-MB09 group.
|
Throughout the Study: Prolia-Prolia
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-Prolia group.
|
|---|---|---|---|---|---|
|
Efficacy: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52 - Full Analysis Set (FAS)
|
5.40 Percentage change (%)
Standard Error 0.26
|
5.38 Percentage change (%)
Standard Error 0.26
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening), Month 6 and Month 12.Population: Modified Full Analysis Set (mFAS) is a subset of subjects in the FAS who met all eligibility criteria. The mFAS term defined a set at the data point level which included a data record at each timepoint for all eligible subjects in the FAS but excluded data observed after the first occurrence of those intercurrent events (ICEs) where a hypothetical strategy was taken (eg, missing a dose, errors or deviations in dosing, or receipt of any prohibited therapies or other osteoporosis medication).
To assess the efficacy of MB09 to EU-Prolia in postmenopausal women with osteoporosis in terms of Lumbar Spine at Month 6 and Total Hip and Femur Neck BMD at Month 6 and Month12. The difference in means in %CfB in lumbar spine BMD between MB09 and Prolia at Month 6 and Total Hip and Femur Neck at Month 6 and Month 12 from an MMRM presented for the mFAS. Bone density measurements were performed by DXA. All DXA scans were submitted to a central imaging vendor for analysis.
Outcome measures
| Measure |
MB09
n=258 Participants
A total of 2 subcutaneous administration of 60 mg MB09 (proposed denosumab biosimilar) on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
EU-Prolia
n=266 Participants
A total of 2 subcutaneous administration of 60 mg Prolia on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
Throughout the Study: MB09-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for MB09-MB09 group.
|
Throughout the Study: Prolia-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-MB09 group.
|
Throughout the Study: Prolia-Prolia
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-Prolia group.
|
|---|---|---|---|---|---|
|
Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine at Month 6 and Total Hip and Femur Neck BMD at Month 6 and Month12 - MMRM on mFAS
Femur Neck - Month 12
|
2.75 percentage change (%)
Standard Error 0.23
|
2.39 percentage change (%)
Standard Error 0.23
|
—
|
—
|
—
|
|
Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine at Month 6 and Total Hip and Femur Neck BMD at Month 6 and Month12 - MMRM on mFAS
Total Hip - Month 12
|
3.37 percentage change (%)
Standard Error 0.18
|
3.28 percentage change (%)
Standard Error 0.17
|
—
|
—
|
—
|
|
Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine at Month 6 and Total Hip and Femur Neck BMD at Month 6 and Month12 - MMRM on mFAS
Lumbar Spine - Month 6
|
4.03 percentage change (%)
Standard Error 0.23
|
3.96 percentage change (%)
Standard Error 0.22
|
—
|
—
|
—
|
|
Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine at Month 6 and Total Hip and Femur Neck BMD at Month 6 and Month12 - MMRM on mFAS
Total Hip - Month 6
|
2.29 percentage change (%)
Standard Error 0.16
|
2.46 percentage change (%)
Standard Error 0.16
|
—
|
—
|
—
|
|
Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine at Month 6 and Total Hip and Femur Neck BMD at Month 6 and Month12 - MMRM on mFAS
Femur Neck - Month 6
|
2.18 percentage change (%)
Standard Error 0.22
|
1.93 percentage change (%)
Standard Error 0.21
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening), Month 6, Month 12.Population: The Full Analysis Set (FAS) consisted of all consenting randomised subjects who received at least one dose of study treatment.
To assess the efficacy of MB09 to EU-Prolia in postmenopausal women with osteoporosis in terms of the difference in means (MB09-Prolia) in the %CfB in Lumbar Spine BMD at Month 6 and Total Hip and Femur Neck BMD at Month 6 and 12 in postmenopausal women with osteoporosis treated with SC denosumab injections every 6 months. This included all subjects and data records irrespective of failed eligibility criteria, receipt of prohibited medications, discontinued treatment for any reason, had errors or deviations in dosing, or receipt of both doses. Bone density measurement were performed by DXA. All DXA scans were submitted to a central imaging vendor for analysis.
Outcome measures
| Measure |
MB09
n=278 Participants
A total of 2 subcutaneous administration of 60 mg MB09 (proposed denosumab biosimilar) on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
EU-Prolia
n=277 Participants
A total of 2 subcutaneous administration of 60 mg Prolia on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
Throughout the Study: MB09-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for MB09-MB09 group.
|
Throughout the Study: Prolia-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-MB09 group.
|
Throughout the Study: Prolia-Prolia
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-Prolia group.
|
|---|---|---|---|---|---|
|
Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine BMD at Month 6 and Total Hip and Femur Neck BMD at Month 6 and 12 - ANCOVA on FAS
Total Hip - Month 12
|
3.31 percentage change (%)
Standard Error 0.17
|
3.27 percentage change (%)
Standard Error 0.17
|
—
|
—
|
—
|
|
Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine BMD at Month 6 and Total Hip and Femur Neck BMD at Month 6 and 12 - ANCOVA on FAS
Femur Neck- Month 12
|
2.70 percentage change (%)
Standard Error 0.23
|
2.38 percentage change (%)
Standard Error 0.22
|
—
|
—
|
—
|
|
Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine BMD at Month 6 and Total Hip and Femur Neck BMD at Month 6 and 12 - ANCOVA on FAS
Lumbar Spine - Month 6
|
3.82 percentage change (%)
Standard Error 0.22
|
3.92 percentage change (%)
Standard Error 0.22
|
—
|
—
|
—
|
|
Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine BMD at Month 6 and Total Hip and Femur Neck BMD at Month 6 and 12 - ANCOVA on FAS
Total Hip - Month 6
|
2.28 percentage change (%)
Standard Error 0.16
|
2.49 percentage change (%)
Standard Error 0.16
|
—
|
—
|
—
|
|
Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine BMD at Month 6 and Total Hip and Femur Neck BMD at Month 6 and 12 - ANCOVA on FAS
Femur Neck - Month 6
|
2.18 percentage change (%)
Standard Error 0.21
|
1.92 percentage change (%)
Standard Error 0.21
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-dose Day 1), up to Month 6.Population: Modified Full Analysis Set (mFAS)
Geometric meant (geometric CV%) sCTX Area under the effect curve from zero to 6 months (AUEC0-6 months) after first dose in postmenopausal women with osteoporosis treated with SC denosumab injections every 6 months assuming all women received their first denosumab dose without any errors in dosing and without receipt of any prohibited therapies or other osteoporosis medications up to 6 months after first dose.
Outcome measures
| Measure |
MB09
n=218 Participants
A total of 2 subcutaneous administration of 60 mg MB09 (proposed denosumab biosimilar) on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
EU-Prolia
n=228 Participants
A total of 2 subcutaneous administration of 60 mg Prolia on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
Throughout the Study: MB09-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for MB09-MB09 group.
|
Throughout the Study: Prolia-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-MB09 group.
|
Throughout the Study: Prolia-Prolia
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-Prolia group.
|
|---|---|---|---|---|---|
|
Pharmacodynamics: Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (sCTX) Area Under the Effect Curve From Zero to 6 Months (AUEC0-6 Months) After First Dose - Modified Full Analysis Set (mFAS)
|
12300 day*pg/mL
Geometric Coefficient of Variation 49.7
|
12400 day*pg/mL
Geometric Coefficient of Variation 44.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-dose Day 1), up to Month 6.Population: Modified Full Analysis Set (mFAS)
AUIC0-6 months = Area under the inhibition curve for % change from baseline sCTX concentrations from time zero to 6 months
Outcome measures
| Measure |
MB09
n=218 Participants
A total of 2 subcutaneous administration of 60 mg MB09 (proposed denosumab biosimilar) on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
EU-Prolia
n=228 Participants
A total of 2 subcutaneous administration of 60 mg Prolia on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
Throughout the Study: MB09-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for MB09-MB09 group.
|
Throughout the Study: Prolia-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-MB09 group.
|
Throughout the Study: Prolia-Prolia
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-Prolia group.
|
|---|---|---|---|---|---|
|
Pharmacodynamics: %CfB Area Under the Percent Inhibition Curve From Time Zero to 6 Months (AUIC0-6 Months) in sCTX - on mFAS
|
15100 day* %
Geometric Coefficient of Variation 17.4
|
15300 day* %
Geometric Coefficient of Variation 13.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-dose Day 1), up to Month 6Population: Pharmacokinetic Parameter Analysis Set (PKPS) comprises all subjects who have at least three measurable concentrations in PKCS which must include Day 11 to allow for reliable estimation of both Cmax and AUC0-6 months.
To assess the PK profile of MB09 compared with EU-Prolia following the first dose, maximum Observed Serum Concentration (Cmax) of Denosumab After First Dose study treatment (Pharmacokinetic Parameter Analysis Set).
Outcome measures
| Measure |
MB09
n=269 Participants
A total of 2 subcutaneous administration of 60 mg MB09 (proposed denosumab biosimilar) on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
EU-Prolia
n=273 Participants
A total of 2 subcutaneous administration of 60 mg Prolia on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
Throughout the Study: MB09-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for MB09-MB09 group.
|
Throughout the Study: Prolia-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-MB09 group.
|
Throughout the Study: Prolia-Prolia
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-Prolia group.
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Observed Serum Concentration (Cmax) of Denosumab After First Dose Study Treatment (Pharmacokinetic Parameter Analysis Set)
|
5960 ng/mL
Geometric Coefficient of Variation 31.1
|
5700 ng/mL
Geometric Coefficient of Variation 35.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-dose Day 1), up to Month 6.Population: Pharmacokinetic Parameter Analysis Set (PKPS) comprises all subjects who have at least three measurable concentrations in PKCS wich must include Day 11 to allow for reliable estimation of both Cmax and AUC0-6 months.
Area under the concentration-time curve from time zero to 6 months analysed on the log scale by ANCOVA. The model will include treatment and stratification variables (baseline BMD T-score at the lumbar spine (≤ -3.0 and \> -3.0 SD), body mass index (\< 25 and ≥ 25 kg/m2), age at study entry (≥ 55 to \< 68 years versus ≥ 68 to ≤ 80 years) and prior bisphosphonate medication use at study entry (prior use of bisphosphonates versus no prior bisphosphonate use as fixed effects. The estimated mean difference with 95% CI will be back-transformed to give the ratio of geometric means (MB09/EU-Prolia) with 95% CI following the first dose in the Main Treatment Period.
Outcome measures
| Measure |
MB09
n=256 Participants
A total of 2 subcutaneous administration of 60 mg MB09 (proposed denosumab biosimilar) on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
EU-Prolia
n=260 Participants
A total of 2 subcutaneous administration of 60 mg Prolia on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
Throughout the Study: MB09-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for MB09-MB09 group.
|
Throughout the Study: Prolia-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-MB09 group.
|
Throughout the Study: Prolia-Prolia
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-Prolia group.
|
|---|---|---|---|---|---|
|
Pharmacokinetics: To Assess the PK Profile of MB09 Compared With EU Prolia (AUC0-6 Months) Following the First Dose
|
360,000 day*ng/mL
Geometric Coefficient of Variation 36.5
|
337000 day*ng/mL
Geometric Coefficient of Variation 39.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first administration of study treatment on Day 1 until Month 18Population: The Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP)
For Main Treatment Period, treatment-emergent adverse event (TEAE) was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
Outcome measures
| Measure |
MB09
n=277 Participants
A total of 2 subcutaneous administration of 60 mg MB09 (proposed denosumab biosimilar) on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
EU-Prolia
n=278 Participants
A total of 2 subcutaneous administration of 60 mg Prolia on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
Throughout the Study: MB09-MB09
n=277 Participants
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for MB09-MB09 group.
|
Throughout the Study: Prolia-MB09
n=140 Participants
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-MB09 group.
|
Throughout the Study: Prolia-Prolia
n=138 Participants
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-Prolia group.
|
|---|---|---|---|---|---|
|
Safety: Overall Summary of Adverse Events - Main Treatment Period - Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP)
Any TEAEs
|
161 Participants
|
150 Participants
|
180 Participants
|
87 Participants
|
75 Participants
|
|
Safety: Overall Summary of Adverse Events - Main Treatment Period - Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP)
Any study treatment-related TEAEs
|
41 Participants
|
24 Participants
|
45 Participants
|
11 Participants
|
17 Participants
|
|
Safety: Overall Summary of Adverse Events - Main Treatment Period - Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP)
Any serious TEAEs
|
19 Participants
|
13 Participants
|
21 Participants
|
11 Participants
|
4 Participants
|
|
Safety: Overall Summary of Adverse Events - Main Treatment Period - Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP)
Any study treatment-related serious TEAEs
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: All participants in the Main Treatment Period and Transition Period (From Day 1 untill Month 18)Population: Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP)
For the Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
Outcome measures
| Measure |
MB09
n=277 Participants
A total of 2 subcutaneous administration of 60 mg MB09 (proposed denosumab biosimilar) on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
EU-Prolia
n=140 Participants
A total of 2 subcutaneous administration of 60 mg Prolia on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
Throughout the Study: MB09-MB09
n=138 Participants
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for MB09-MB09 group.
|
Throughout the Study: Prolia-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-MB09 group.
|
Throughout the Study: Prolia-Prolia
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-Prolia group.
|
|---|---|---|---|---|---|
|
Safety: New Clinical Bone Fractures - TEAEs (Throughout the Study - From Day 1 Untill Month 18)
Number of subjects with at least one fracture TEAE (any bone)
|
12 Participants
|
6 Participants
|
4 Participants
|
—
|
—
|
|
Safety: New Clinical Bone Fractures - TEAEs (Throughout the Study - From Day 1 Untill Month 18)
Number of subjects with at least one Vertebral fracture
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Safety: New Clinical Bone Fractures - TEAEs (Throughout the Study - From Day 1 Untill Month 18)
Number of subjects with at least one Hip fracture
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Safety: New Clinical Bone Fractures - TEAEs (Throughout the Study - From Day 1 Untill Month 18)
Number of subjects with at least one Pelvic fracture
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (pre-dose) up to and including Month 18.Population: Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP)
Number of subjects experiencing treatment-induced immunogenicity: Binding and neutralising serum denosumab antibodies from baseline up to and including Month 18. Analysis of immunogenicity data will be based on ADA evaluable subjects defined as all SAF or SAF-TP subjects with baseline and at least one post-baseline immunogenicity assessment within the Main Treatment Period or the Transition Period. The formation of ADAs against MB09 or EU-Prolia was assessed in blood samples.
Outcome measures
| Measure |
MB09
n=277 Participants
A total of 2 subcutaneous administration of 60 mg MB09 (proposed denosumab biosimilar) on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
EU-Prolia
n=140 Participants
A total of 2 subcutaneous administration of 60 mg Prolia on Day 1 and Month 6 in the Main Treatment Period (MTP).
|
Throughout the Study: MB09-MB09
n=138 Participants
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for MB09-MB09 group.
|
Throughout the Study: Prolia-MB09
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-MB09 group.
|
Throughout the Study: Prolia-Prolia
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for Prolia-Prolia group.
|
|---|---|---|---|---|---|
|
Overall Incidence of Antidrug Antibodies (ADA) - Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP)
ADA positive
|
1 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Overall Incidence of Antidrug Antibodies (ADA) - Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP)
NAb positive
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
Main Treatment Period: MB09
Serious events: 19 serious events
Other events: 120 other events
Deaths: 0 deaths
Main Treatment Period: EU-Prolia
Serious events: 13 serious events
Other events: 120 other events
Deaths: 0 deaths
Throughout the Study: MB09-MB09
Serious events: 21 serious events
Other events: 180 other events
Deaths: 1 deaths
Throughout the Study: EU Prolia-MB09
Serious events: 11 serious events
Other events: 87 other events
Deaths: 0 deaths
Throughout the Study: EU Prolia-EU Prolia
Serious events: 4 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main Treatment Period: MB09
n=277 participants at risk
From first administration of study treatment on Day 1 until Month 12 (pre-dose) displayed for MB09 group.
|
Main Treatment Period: EU-Prolia
n=278 participants at risk
From first administration of study treatment on Day 1 until Month 12 (pre-dose) displayed for EU-Prolia group.
|
Throughout the Study: MB09-MB09
n=277 participants at risk
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for MB09-MB09 group.
|
Throughout the Study: EU Prolia-MB09
n=140 participants at risk
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for EU Prolia-MB09 group.
|
Throughout the Study: EU Prolia-EU Prolia
n=138 participants at risk
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for EU Prolia-EU Prolia group.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Cardiac disorders
Atrial fibrillation
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.72%
1/138 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Gastrointestinal disorders
Gastritis
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Infections and infestations
Pneumonia
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.72%
2/277 • Number of events 2 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.72%
1/138 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.72%
1/138 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Musculoskeletal and connective tissue disorders
Ulna fracture
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma metastatic
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
General disorders
Nodule
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Hepatobiliary disorders
Steatohepatitis
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.72%
1/138 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Nervous system disorders
Migraine
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.72%
1/138 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Endocrine disorders
Goitre
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Endocrine disorders
Toxic goitre
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/278 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/140 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.72%
1/138 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
Other adverse events
| Measure |
Main Treatment Period: MB09
n=277 participants at risk
From first administration of study treatment on Day 1 until Month 12 (pre-dose) displayed for MB09 group.
|
Main Treatment Period: EU-Prolia
n=278 participants at risk
From first administration of study treatment on Day 1 until Month 12 (pre-dose) displayed for EU-Prolia group.
|
Throughout the Study: MB09-MB09
n=277 participants at risk
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for MB09-MB09 group.
|
Throughout the Study: EU Prolia-MB09
n=140 participants at risk
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for EU Prolia-MB09 group.
|
Throughout the Study: EU Prolia-EU Prolia
n=138 participants at risk
Cumulative safety data throughout the study (baseline to the end of Transition Period \[Month 18\]) displayed for EU Prolia-EU Prolia group.
|
|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
7.2%
20/277 • Number of events 20 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
7.2%
20/278 • Number of events 22 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
9.0%
25/277 • Number of events 30 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
9.3%
13/140 • Number of events 15 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
8.7%
12/138 • Number of events 14 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
15/277 • Number of events 16 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
5.4%
15/278 • Number of events 15 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
6.1%
17/277 • Number of events 18 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
3.6%
5/140 • Number of events 6 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
7.2%
10/138 • Number of events 10 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Infections and infestations
COVID-19
|
5.1%
14/277 • Number of events 14 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
5.4%
15/278 • Number of events 15 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
7.6%
21/277 • Number of events 21 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
7.9%
11/140 • Number of events 11 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
7.2%
10/138 • Number of events 10 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Investigations
Blood parathyroid hormone increased
|
4.0%
11/277 • Number of events 12 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.4%
4/278 • Number of events 4 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
4.0%
11/277 • Number of events 12 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.4%
2/140 • Number of events 2 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.4%
2/138 • Number of events 2 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Vascular disorders
Hypertension
|
3.6%
10/277 • Number of events 10 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.2%
6/278 • Number of events 6 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
3.6%
10/277 • Number of events 10 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.9%
4/140 • Number of events 4 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
4.3%
6/138 • Number of events 6 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
10/277 • Number of events 10 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
8.3%
23/278 • Number of events 23 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
5.4%
15/277 • Number of events 15 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
10.7%
15/140 • Number of events 16 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
8.0%
11/138 • Number of events 11 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.2%
9/277 • Number of events 12 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
3.6%
10/278 • Number of events 13 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
4.0%
11/277 • Number of events 14 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.9%
4/140 • Number of events 5 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
5.1%
7/138 • Number of events 9 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Infections and infestations
Urinary tract infection
|
3.2%
9/277 • Number of events 13 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
3.2%
9/278 • Number of events 12 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
6.5%
18/277 • Number of events 23 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
5.7%
8/140 • Number of events 12 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.4%
2/138 • Number of events 3 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
7/277 • Number of events 7 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.4%
4/278 • Number of events 4 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.9%
8/277 • Number of events 8 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.4%
2/140 • Number of events 2 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.2%
3/138 • Number of events 3 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Endocrine disorders
Hypothyroidism
|
2.2%
6/277 • Number of events 6 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.2%
6/278 • Number of events 6 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.5%
7/277 • Number of events 8 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.9%
4/140 • Number of events 4 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.4%
2/138 • Number of events 2 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
6/277 • Number of events 7 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.5%
7/278 • Number of events 7 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.5%
7/277 • Number of events 8 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
3.6%
5/140 • Number of events 5 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.2%
3/138 • Number of events 3 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.2%
6/277 • Number of events 6 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.8%
5/278 • Number of events 6 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.9%
8/277 • Number of events 8 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.9%
4/140 • Number of events 5 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.2%
3/138 • Number of events 3 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Eye disorders
Cataract
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.5%
7/277 • Number of events 9 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.1%
3/140 • Number of events 4 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.4%
2/138 • Number of events 2 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Nervous system disorders
Headache
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.5%
7/277 • Number of events 8 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.1%
3/140 • Number of events 3 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.4%
2/138 • Number of events 2 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.5%
7/277 • Number of events 7 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
3.6%
5/140 • Number of events 5 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.72%
1/138 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.2%
6/277 • Number of events 8 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.4%
2/140 • Number of events 2 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.4%
2/138 • Number of events 2 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.2%
6/277 • Number of events 6 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.4%
2/138 • Number of events 3 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.8%
5/277 • Number of events 5 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.1%
3/140 • Number of events 3 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.9%
4/138 • Number of events 4 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Infections and infestations
Cystitis
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.4%
4/277 • Number of events 4 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.2%
3/138 • Number of events 3 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.1%
3/277 • Number of events 3 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.9%
4/140 • Number of events 4 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/138 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.72%
2/277 • Number of events 2 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.1%
3/140 • Number of events 4 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
1.4%
2/138 • Number of events 2 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Infections and infestations
Influenza
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.72%
2/277 • Number of events 3 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.1%
3/140 • Number of events 3 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.72%
1/138 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.72%
2/277 • Number of events 2 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.9%
4/138 • Number of events 5 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.72%
2/277 • Number of events 2 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.9%
4/140 • Number of events 4 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.72%
1/138 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
|
Psychiatric disorders
Depression
|
0.00%
0/277 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.00%
0/278 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.36%
1/277 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
0.71%
1/140 • Number of events 1 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
2.2%
3/138 • Number of events 3 • Subject incidence of TEAEs up to and including Month 18.
For Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place