Trial Outcomes & Findings for A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis (NCT NCT04729621)
NCT ID: NCT04729621
Last Updated: 2024-04-18
Results Overview
Percent change from baseline in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 52
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
332 participants
Primary outcome timeframe
Baseline and week 52
Results posted on
2024-04-18
Participant Flow
332 subjects were randomized into the study. Those that completed the Main treatment period were then randomized into the transition period. Therefore, the 3 arms noted as "Transition period" are the same subjects that were included in the "Treatment Period".
Participant milestones
| Measure |
TVB-009 Main Treatment Period
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
TVB-009 Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Main Treatment Period (Week1 to Week 52)
STARTED
|
166
|
166
|
0
|
0
|
0
|
|
Main Treatment Period (Week1 to Week 52)
COMPLETED
|
148
|
143
|
0
|
0
|
0
|
|
Main Treatment Period (Week1 to Week 52)
NOT COMPLETED
|
18
|
23
|
0
|
0
|
0
|
|
Transition Period (Week 52 to Week 78)
STARTED
|
0
|
0
|
148
|
72
|
71
|
|
Transition Period (Week 52 to Week 78)
COMPLETED
|
0
|
0
|
140
|
67
|
69
|
|
Transition Period (Week 52 to Week 78)
NOT COMPLETED
|
0
|
0
|
8
|
5
|
2
|
Reasons for withdrawal
| Measure |
TVB-009 Main Treatment Period
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
TVB-009 Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Main Treatment Period (Week1 to Week 52)
Adverse Event
|
3
|
7
|
0
|
0
|
0
|
|
Main Treatment Period (Week1 to Week 52)
Withdrawal by Subject
|
13
|
12
|
0
|
0
|
0
|
|
Main Treatment Period (Week1 to Week 52)
Multiple Other Reasons
|
2
|
4
|
0
|
0
|
0
|
|
Transition Period (Week 52 to Week 78)
Withdrawal by Subject
|
0
|
0
|
7
|
2
|
1
|
|
Transition Period (Week 52 to Week 78)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Transition Period (Week 52 to Week 78)
Multiple Other Reasons
|
0
|
0
|
1
|
2
|
1
|
Baseline Characteristics
Calcium \& Vitamin D Supplement status was only required for patients that experienced any fractures prior to study start.
Baseline characteristics by cohort
| Measure |
TVB-009 Main Treatment Period
n=166 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=166 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
Total
n=332 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 5.69 • n=166 Participants
|
67.7 years
STANDARD_DEVIATION 5.56 • n=166 Participants
|
68.1 years
STANDARD_DEVIATION 5.63 • n=332 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=166 Participants
|
166 Participants
n=166 Participants
|
332 Participants
n=332 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=166 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=332 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=166 Participants
|
18 Participants
n=166 Participants
|
41 Participants
n=332 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
143 Participants
n=166 Participants
|
148 Participants
n=166 Participants
|
291 Participants
n=332 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=166 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=332 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=166 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=332 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=166 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=332 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=166 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=332 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=166 Participants
|
1 Participants
n=166 Participants
|
2 Participants
n=332 Participants
|
|
Race (NIH/OMB)
White
|
165 Participants
n=166 Participants
|
164 Participants
n=166 Participants
|
329 Participants
n=332 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=166 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=332 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=166 Participants
|
1 Participants
n=166 Participants
|
1 Participants
n=332 Participants
|
|
Region of Enrollment
Hungary
|
11 participants
n=166 Participants
|
6 participants
n=166 Participants
|
17 participants
n=332 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=166 Participants
|
35 participants
n=166 Participants
|
69 participants
n=332 Participants
|
|
Region of Enrollment
Czechia
|
21 participants
n=166 Participants
|
19 participants
n=166 Participants
|
40 participants
n=332 Participants
|
|
Region of Enrollment
Ukraine
|
13 participants
n=166 Participants
|
12 participants
n=166 Participants
|
25 participants
n=332 Participants
|
|
Region of Enrollment
Poland
|
30 participants
n=166 Participants
|
37 participants
n=166 Participants
|
67 participants
n=332 Participants
|
|
Region of Enrollment
Georgia
|
17 participants
n=166 Participants
|
9 participants
n=166 Participants
|
26 participants
n=332 Participants
|
|
Region of Enrollment
Slovakia
|
6 participants
n=166 Participants
|
13 participants
n=166 Participants
|
19 participants
n=332 Participants
|
|
Region of Enrollment
Bulgaria
|
22 participants
n=166 Participants
|
20 participants
n=166 Participants
|
42 participants
n=332 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=166 Participants
|
1 participants
n=166 Participants
|
2 participants
n=332 Participants
|
|
Region of Enrollment
Russia
|
11 participants
n=166 Participants
|
14 participants
n=166 Participants
|
25 participants
n=332 Participants
|
|
Previous Use of Biophosphonates
Yes
|
21 Participants
n=166 Participants
|
21 Participants
n=166 Participants
|
42 Participants
n=332 Participants
|
|
Previous Use of Biophosphonates
No
|
145 Participants
n=166 Participants
|
145 Participants
n=166 Participants
|
290 Participants
n=332 Participants
|
|
Prior Fractures
Yes
|
37 Participants
n=166 Participants
|
38 Participants
n=166 Participants
|
75 Participants
n=332 Participants
|
|
Prior Fractures
No
|
129 Participants
n=166 Participants
|
128 Participants
n=166 Participants
|
257 Participants
n=332 Participants
|
|
Taking Calcium & Vitamin D Supplements
Yes
|
28 Participants
n=37 Participants • Calcium \& Vitamin D Supplement status was only required for patients that experienced any fractures prior to study start.
|
28 Participants
n=38 Participants • Calcium \& Vitamin D Supplement status was only required for patients that experienced any fractures prior to study start.
|
56 Participants
n=75 Participants • Calcium \& Vitamin D Supplement status was only required for patients that experienced any fractures prior to study start.
|
|
Taking Calcium & Vitamin D Supplements
No
|
9 Participants
n=37 Participants • Calcium \& Vitamin D Supplement status was only required for patients that experienced any fractures prior to study start.
|
10 Participants
n=38 Participants • Calcium \& Vitamin D Supplement status was only required for patients that experienced any fractures prior to study start.
|
19 Participants
n=75 Participants • Calcium \& Vitamin D Supplement status was only required for patients that experienced any fractures prior to study start.
|
PRIMARY outcome
Timeframe: Baseline and week 52Population: The mITT population was used for this analysis. The modified intent-to-treat (mITT) analysis set will include all randomized patients who received at least 1 dose of IMP and had at least 1 post-baseline evaluation of LS-BMD
Percent change from baseline in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 52
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=157 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=152 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in LS-BMD at Week 52
|
4.76 percentage of change from baseline
Interval 3.82 to 5.69
|
4.54 percentage of change from baseline
Interval 3.62 to 5.47
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 26Population: The mITT was used for this analysis. The modified intent-to-treat (mITT) analysis set includes all randomized patients who received at least 1 dose of IMP and had at least 1 post-baseline evaluation of LS-BMD
Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen at week 26
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=157 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=152 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in sCTX-1 at Week 26
|
-56.05 percentage of change from baseline
Interval -64.99 to -47.12
|
-65.13 percentage of change from baseline
Interval -74.09 to -56.17
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 26Population: The mITT population was used in this analysis.
Percent change from baseline in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 26
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=157 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=151 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in LS-BMD at Week 26
|
3.70 percentage of change from baseline
Standard Deviation 4.294
|
3.62 percentage of change from baseline
Standard Deviation 3.815
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 26Population: mITT population was used for this analysis.
Percent change from baseline in femoral neck bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA)at week 26
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=156 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=150 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Femoral Neck BMD at Week 26
|
1.87 percentage of change from baseline
Standard Deviation 4.877
|
2.01 percentage of change from baseline
Standard Deviation 3.611
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 26Population: mITT population was used for the analysis.
Percent change from baseline in total hip bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 26
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=156 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=150 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Hip BMD at Week 26
|
1.89 percentage of change from baseline
Standard Deviation 3.488
|
2.02 percentage of change from baseline
Standard Deviation 2.526
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: mITT population was used for this analysis.
Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=151 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=146 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in sCTX-1
|
-57.91 percentage of change from baseline
Standard Deviation 44.161
|
-68.80 percentage of change from baseline
Standard Deviation 35.846
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4Population: mITT population was used.
Proportion of patients with suppression of serum C-telopeptide cross-link of type 1 collagen at week 4
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=155 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=151 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Percentage of Participatns With sCTX-1 Suppression at Week 4
|
94.2 Percentage of participants
|
94.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: mITT population was used for this analysis.
Percent change from baseline in procollagen type 1 N propeptide (P1NP) to Week 52
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=151 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=146 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in P1NP
|
-56.43 percentage of change from baseline
Standard Deviation 35.431
|
-62.03 percentage of change from baseline
Standard Deviation 33.712
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: mITT population was used.
Number of patients with who experienced any new fractures up to week 52.
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=157 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=152 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Number of Fractures up to Week 52
|
3 number participants with fractures
|
5 number participants with fractures
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52 through week 78Population: TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD.
Percent change from week 52 in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 78
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=137 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=62 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
n=68 Participants
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Percent Change From Week 52 in LS-BMD by DXA at Week 78
|
0.82 percentage of change from baseline
Standard Deviation 3.120
|
1.15 percentage of change from baseline
Standard Deviation 3.440
|
1.24 percentage of change from baseline
Standard Deviation 3.069
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52 through week 78Population: TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD.
Percent change from week 52 in femoral neck bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 78
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=137 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=62 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
n=68 Participants
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Percent Change From Week 52 in Femoral Neck BMD by DXA at Week 78
|
0.38 Percent change from week 52
Standard Deviation 3.525
|
0.80 Percent change from week 52
Standard Deviation 3.560
|
0.94 Percent change from week 52
Standard Deviation 3.082
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52 through week 78Population: TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD.
Percent change from week 52 in total hip bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 78
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=137 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=62 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
n=68 Participants
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Percent Change From Week 52 in Total Hip BMD by DXA at Week 78
|
0.01 Percent change from week 52
Standard Deviation 2.089
|
0.66 Percent change from week 52
Standard Deviation 2.109
|
0.27 Percent change from week 52
Standard Deviation 2.264
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52, Week 78Population: TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD.
Difference in the percent change from baseline in serum C-telopeptide cross-link of type 1 collagen from baseline to Week 78 as compared to baseline to Week 52
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=137 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=63 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
n=69 Participants
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Difference Between Percent Change From Baseline in sCTX-1 Between Week 52 and Week 78
|
9.95 Percent change from baseline
Standard Deviation 41.612
|
13.17 Percent change from baseline
Standard Deviation 28.558
|
7.55 Percent change from baseline
Standard Deviation 36.509
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52, Week 78Population: TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD.
The difference in the Percent change from baseline in procollagen type 1 N propeptide at Week 78 compared to Week 52.
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=137 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=63 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
n=69 Participants
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Difference Between Percent Change From Baseline in P1NP Between Week 52 and Week 78
|
3.95 Percent change
Standard Deviation 23.376
|
4.83 Percent change
Standard Deviation 14.551
|
2.89 Percent change
Standard Deviation 39.804
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52 through week 78Population: TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD.
Number of patients experiencing new fractures between week 52 and week 78
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=138 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=64 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
n=69 Participants
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Number of Patients With Fractures Between Week 52 and Week 78
|
1 Number participants with fractures
|
0 Number participants with fractures
|
1 Number participants with fractures
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: Safety Analysis Set (SAS) was used. The safety analysis set will include all randomized patients who received at least 1 dose of IMP.
Number of patients reporting at least one treatment-emergent adverse event up to week 52
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=166 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=165 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Incidence of Adverse Event
TEAE Related to Study Drug
|
19 Participants
|
13 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Event
TEAE Related to Medical Device
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Event
TEAE Not Related to Study Drug
|
104 Participants
|
95 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Event
No TEAEs Reported
|
43 Participants
|
57 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52 through week 78Population: Transition Safety Analysis Set was used. The transition safety analysis set will include all patients who received the third dose of the IMP.
Number of patients reporting at least one treatment-emergent adverse event between weeks 52 and 78
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=148 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=72 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
n=71 Participants
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Incidence of Adverse Events in the Transition Period
TEAE Related to Study Drug
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Incidence of Adverse Events in the Transition Period
TEAE Related to Medical Device
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Incidence of Adverse Events in the Transition Period
TEAE Not Related to Study Drug
|
48 Participants
|
20 Participants
|
26 Participants
|
—
|
—
|
|
Incidence of Adverse Events in the Transition Period
No TEAE Reported
|
98 Participants
|
52 Participants
|
45 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Anytime Post Baseline through Week 52Population: The Safety Analysis Set was used. The safety analysis set will include all randomized patients who received at least 1 dose of IMP.
Number of patients with confirmed positive antidrug antibodies (ADAs) post-baseline through Week 52
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=166 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=165 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period
ADA Status · Negative
|
147 Participants
|
129 Participants
|
—
|
—
|
—
|
|
Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period
ADA Status · Positive
|
11 Participants
|
25 Participants
|
—
|
—
|
—
|
|
Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period
ADA Status · Positive, Not Treatment Related
|
8 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period
Neutralizing ADA Status Among Positive · Positive
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period
Neutralizing ADA Status Among Positive · Positive, Not Treatment Related
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period
Neutralizing ADA Status Among Positive · Negative
|
10 Participants
|
23 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Anytime in Week 52 through Week 78Population: The Transition Safety Analysis Set was used. The transition safety analysis set will include all patients who received the third dose of the IMP.
Number of patients with confirmed positive antidrug antibodies (ADAs) at Week 65
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=147 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=70 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
n=70 Participants
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Incidence of Antidrug Antibodies (ADAs) in the Transition Period
Neutralizing ADA Status Among Positive · Positive, Not Treatment Related
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Incidence of Antidrug Antibodies (ADAs) in the Transition Period
Neutralizing ADA Status Among Positive · Negative
|
6 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Incidence of Antidrug Antibodies (ADAs) in the Transition Period
ADA Status · Positive
|
7 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Incidence of Antidrug Antibodies (ADAs) in the Transition Period
ADA Status · Positive, Not Treatment Related
|
7 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Incidence of Antidrug Antibodies (ADAs) in the Transition Period
ADA Status · Negative
|
133 Participants
|
61 Participants
|
65 Participants
|
—
|
—
|
|
Incidence of Antidrug Antibodies (ADAs) in the Transition Period
Neutralizing ADA Status Among Positive · Positive
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: mITT population was used for this analysis.
Percent change from baseline in femoral neck bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA)at week 52
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=150 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=145 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Femoral Neck BMD at Week 52
|
2.39 Percent change from baseline
Standard Deviation 5.795
|
2.34 Percent change from baseline
Standard Deviation 3.780
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: mITT population was used for the analysis.
Percent change from baseline in total hip bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 52
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=150 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=145 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Hip BMD at Week 52
|
2.67 Percent change from baseline
Standard Deviation 3.981
|
3.00 Percent change from baseline
Standard Deviation 2.768
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Main Treatment Period = Baseline-Week 52; Transition period = Week 52-78Population: Safety Analysis Set
Number of patients that withdraw or are removed from the study due to treatment emergent adverse events from both the main and transition treatment periods.
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=166 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=165 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
n=148 Participants
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
n=72 Participants
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
n=71 Participants
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Number of TEAEs Leading to Patient Withdraw From the Study
|
3 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Main Treatment Period = Day 1 & Week 26; Transition Treatment Period = Week 52Population: Safety Analysis Set
Number of patients who report Injection Site Reactions at Day 1, Week 26, or Week 52.
Outcome measures
| Measure |
TVB-009 Main Treatment Period
n=166 Participants
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=165 Participants
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
n=148 Participants
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
n=72 Participants
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
n=71 Participants
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Local Tolerability at Injection Site
Day 1 · Erythema
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Day 1 · Ecchymosis
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Day 1 · Induration
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Day 1 · Tenderness
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Day 1 · Warmth
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Day 1 · Swelling
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Day 1 · Pain
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Day 1 · No Reaction
|
144 Participants
|
145 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Week 26 · Erythema
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Week 26 · Ecchymosis
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Week 26 · Induration
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Week 26 · Tenderness
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Week 26 · Warmth
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Week 26 · Swelling
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Week 26 · Pain
|
7 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Week 26 · No Reaction
|
142 Participants
|
142 Participants
|
—
|
—
|
—
|
|
Local Tolerability at Injection Site
Week 52 · Erythema
|
—
|
—
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Local Tolerability at Injection Site
Week 52 · Ecchymosis
|
—
|
—
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Local Tolerability at Injection Site
Week 52 · Induration
|
—
|
—
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Local Tolerability at Injection Site
Week 52 · Tenderness
|
—
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Local Tolerability at Injection Site
Week 52 · Warmth
|
—
|
—
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Local Tolerability at Injection Site
Week 52 · Swelling
|
—
|
—
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Local Tolerability at Injection Site
Week 52 · Pain
|
—
|
—
|
6 Participants
|
4 Participants
|
3 Participants
|
|
Local Tolerability at Injection Site
Week 52 · No Reaction
|
—
|
—
|
133 Participants
|
59 Participants
|
63 Participants
|
Adverse Events
TVB-009 Main Treatment Period
Serious events: 8 serious events
Other events: 123 other events
Deaths: 0 deaths
PROLIA Main Treatment Period
Serious events: 6 serious events
Other events: 108 other events
Deaths: 0 deaths
TVB-009 Main / TVB-009 Transition Period
Serious events: 5 serious events
Other events: 42 other events
Deaths: 0 deaths
PROLIA Main / PROLIA Transition Period
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
PROLIA Main / TVB-009 Transition Period
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TVB-009 Main Treatment Period
n=166 participants at risk
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=165 participants at risk
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
TVB-009 Main / TVB-009 Transition Period
n=148 participants at risk
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
n=72 participants at risk
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
n=71 participants at risk
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/166 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.61%
1/165 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/166 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.61%
1/165 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Endocrine disorders
Adrenal mass
|
0.60%
1/166 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/165 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.60%
1/166 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/165 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/166 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.61%
1/165 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.60%
1/166 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/165 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
1.4%
1/71 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/166 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.61%
1/165 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.68%
1/148 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Infections and infestations
Hepatitis C
|
0.60%
1/166 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/165 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Infections and infestations
Infective periostitis
|
0.60%
1/166 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/165 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/166 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.61%
1/165 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/166 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.61%
1/165 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.60%
1/166 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/165 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Splenic marginal zone lymphoma
|
0.00%
0/166 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.61%
1/165 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.60%
1/166 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/165 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.60%
1/166 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/165 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
General disorders
Malaise
|
0.00%
0/166 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/165 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.68%
1/148 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/166 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/165 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.68%
1/148 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.00%
0/166 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/165 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.68%
1/148 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/166 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/165 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.68%
1/148 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/166 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/165 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.68%
1/148 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
Other adverse events
| Measure |
TVB-009 Main Treatment Period
n=166 participants at risk
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main Treatment Period
n=165 participants at risk
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
TVB-009 Main / TVB-009 Transition Period
n=148 participants at risk
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / PROLIA Transition Period
n=72 participants at risk
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
PROLIA Main / TVB-009 Transition Period
n=71 participants at risk
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.60%
1/166 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
3.0%
5/165 • Number of events 5 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
1.4%
2/148 • Number of events 2 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
1.4%
1/71 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Infections and infestations
COVID-19
|
10.2%
17/166 • Number of events 17 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
13.3%
22/165 • Number of events 22 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
2.0%
3/148 • Number of events 3 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
1.4%
1/71 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
7/166 • Number of events 7 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
5.5%
9/165 • Number of events 9 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
2.7%
4/148 • Number of events 4 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
6.9%
5/72 • Number of events 5 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
5/166 • Number of events 5 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/165 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
2.0%
3/148 • Number of events 3 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
2.8%
2/72 • Number of events 2 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
1.4%
1/71 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Infections and infestations
Urinary tract infection
|
3.6%
6/166 • Number of events 6 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
1.8%
3/165 • Number of events 3 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.68%
1/148 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
1.4%
1/72 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Investigations
Vitamin D decreased
|
6.0%
10/166 • Number of events 10 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
3.0%
5/165 • Number of events 5 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
1.4%
1/71 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
8.4%
14/166 • Number of events 14 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
11.5%
19/165 • Number of events 19 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
2.7%
4/148 • Number of events 4 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
2.8%
2/72 • Number of events 2 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
2.8%
2/71 • Number of events 2 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
20.5%
34/166 • Number of events 34 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
12.7%
21/165 • Number of events 21 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
1.4%
2/148 • Number of events 2 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.4%
14/166 • Number of events 14 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
7.9%
13/165 • Number of events 13 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
2.7%
4/148 • Number of events 4 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
5.6%
4/72 • Number of events 4 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
9/166 • Number of events 9 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
3.6%
6/165 • Number of events 6 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
5.4%
8/148 • Number of events 8 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
2.8%
2/72 • Number of events 2 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
6/166 • Number of events 6 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
6.1%
10/165 • Number of events 10 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
2.0%
3/148 • Number of events 3 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
4.2%
3/72 • Number of events 3 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Nervous system disorders
Headache
|
9.6%
16/166 • Number of events 16 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
9.1%
15/165 • Number of events 15 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
2.7%
4/148 • Number of events 4 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
1.4%
1/72 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
4.2%
3/71 • Number of events 3 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Vascular disorders
Hypertension
|
4.8%
8/166 • Number of events 8 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
4.8%
8/165 • Number of events 8 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.68%
1/148 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.60%
1/166 • Number of events 1 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
1.2%
2/165 • Number of events 2 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/148 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/72 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
2.8%
2/71 • Number of events 2 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
1.8%
3/166 • Number of events 3 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
1.2%
2/165 • Number of events 2 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
2.0%
3/148 • Number of events 3 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
2.8%
2/72 • Number of events 2 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
0.00%
0/71 • The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI must receive sponsor approval for all publications of study results.
- Publication restrictions are in place
Restriction type: OTHER