Trial Outcomes & Findings for A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis (NCT NCT04757376)
NCT ID: NCT04757376
Last Updated: 2024-06-14
Results Overview
Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA) and assessments of the lumbar spine (L1 to L4) were performed at a central imaging vendor. To evaluate the difference between 2 groups in the primary efficacy endpoint, the percent change from baseline in BMD for lumbar spine (L1 to L4) by DXA at Week 52 was analyzed using an analysis of covariance (ANCOVA) model coupled with multiple imputation assuming the data to be missing at random (MAR).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
479 participants
Primary outcome timeframe
baseline (screening), Week 52 predose
Results posted on
2024-06-14
Participant Flow
The recruitment was conducted in 20 study centers in 4 countries.
The screening period began after the participants had signed the written informed consent form and completed it within 28 days before the 1st randomization (Week 0 Day 1). On Week 0 Day 1, participants were randomized in a 1:1 ratio to receive CT-P41 or US-Prolia during Treatment Period (TP) I. At Week 52 predose, participants in the US-Prolia group were re-randomized 1:1 to either continue US-Prolia or transition to CT-P41. The participants in the CT-P41 group continued with CT-P41 for TP II.
Participant milestones
| Measure |
CT-P41
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
CT-P41 Maintenance
Participants treated with CT-P41 in TP I continued the treatment with CT-P41 as a third dose at Week 52 in TP II
|
US-licensed Prolia Maintenance
Participants treated with US-Prolia in TP I were re-randomized to continue the treatment with US-licensed Prolia as a third dose at Week 52 in TP II
|
Switched to CT-P41
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|---|---|
|
TP I - Week 0, Day 1 to Week 52 Predose
STARTED
|
240
|
239
|
0
|
0
|
0
|
|
TP I - Week 0, Day 1 to Week 52 Predose
COMPLETED
|
221
|
201
|
0
|
0
|
0
|
|
TP I - Week 0, Day 1 to Week 52 Predose
NOT COMPLETED
|
19
|
38
|
0
|
0
|
0
|
|
TP II - Week 52 to Week 78
STARTED
|
0
|
0
|
221
|
100
|
101
|
|
TP II - Week 52 to Week 78
COMPLETED
|
0
|
0
|
220
|
100
|
101
|
|
TP II - Week 52 to Week 78
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
CT-P41
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
CT-P41 Maintenance
Participants treated with CT-P41 in TP I continued the treatment with CT-P41 as a third dose at Week 52 in TP II
|
US-licensed Prolia Maintenance
Participants treated with US-Prolia in TP I were re-randomized to continue the treatment with US-licensed Prolia as a third dose at Week 52 in TP II
|
Switched to CT-P41
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|---|---|
|
TP I - Week 0, Day 1 to Week 52 Predose
Withdrawal by Subject
|
8
|
24
|
0
|
0
|
0
|
|
TP I - Week 0, Day 1 to Week 52 Predose
Adverse Event
|
4
|
5
|
0
|
0
|
0
|
|
TP I - Week 0, Day 1 to Week 52 Predose
Protocol Violation
|
5
|
4
|
0
|
0
|
0
|
|
TP I - Week 0, Day 1 to Week 52 Predose
Lost to Follow-up
|
0
|
3
|
0
|
0
|
0
|
|
TP I - Week 0, Day 1 to Week 52 Predose
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
|
TP I - Week 0, Day 1 to Week 52 Predose
Disease progression
|
0
|
1
|
0
|
0
|
0
|
|
TP I - Week 0, Day 1 to Week 52 Predose
Terminated the study before the initiation of the study treatment
|
1
|
1
|
0
|
0
|
0
|
|
TP II - Week 52 to Week 78
Discontinued the study treatment before the study treatment initiation due to the adverse event
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
Baseline characteristics by cohort
| Measure |
CT-P41
n=240 Participants
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=239 Participants
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
Total
n=479 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.0 years
n=5 Participants
|
66.0 years
n=7 Participants
|
66.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
240 Participants
n=5 Participants
|
239 Participants
n=7 Participants
|
479 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race - White
|
240 Participants
n=5 Participants
|
239 Participants
n=7 Participants
|
479 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity - Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity - Non-Hispanic or Non-Latino
|
240 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
476 Participants
n=5 Participants
|
|
Body mass index
|
24.92 kg/m2
STANDARD_DEVIATION 4.230 • n=5 Participants
|
25.23 kg/m2
STANDARD_DEVIATION 4.328 • n=7 Participants
|
25.08 kg/m2
STANDARD_DEVIATION 4.277 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (screening), Week 52 predosePopulation: The FAS was defined as all participants who received at least 1 full dose of the study drug (CT-P41 or US-licensed Prolia). The total number of participants in FAS was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively. The overall number of participants analyzed represents the number of participants in FAS who had a BMD assessment result for the lumbar spine by DXA at Week 52.
Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA) and assessments of the lumbar spine (L1 to L4) were performed at a central imaging vendor. To evaluate the difference between 2 groups in the primary efficacy endpoint, the percent change from baseline in BMD for lumbar spine (L1 to L4) by DXA at Week 52 was analyzed using an analysis of covariance (ANCOVA) model coupled with multiple imputation assuming the data to be missing at random (MAR).
Outcome measures
| Measure |
CT-P41
n=222 Participants
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=212 Participants
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
Switched to CT-P41
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|
|
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 - Full Analysis Set (FAS)
|
4.9597 percentage change (%)
Standard Error 0.29977
|
5.1528 percentage change (%)
Standard Error 0.32133
|
—
|
SECONDARY outcome
Timeframe: baseline (screening), Week 52 predosePopulation: The overall number of participants analyzed row represents the total number of participants in the FAS. The number analyzed per row represents the number of participants in FAS with lumbar spine, total hip, or femoral neck BMD value at baseline and Week 52.
Bone mineral density was assessed by DXA and assessments of the lumbar spine (L1 to L4), total hip, and femoral neck were performed at a central imaging vendor.
Outcome measures
| Measure |
CT-P41
n=239 Participants
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=238 Participants
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
Switched to CT-P41
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|
|
Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 52 - FAS
Lumbar spine
|
5.4913 percentage change (%)
Standard Deviation 3.79907
|
5.6621 percentage change (%)
Standard Deviation 3.75768
|
—
|
|
Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 52 - FAS
Total hip
|
2.7914 percentage change (%)
Standard Deviation 2.87044
|
2.4253 percentage change (%)
Standard Deviation 2.84061
|
—
|
|
Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 52 - FAS
Femoral neck
|
2.2295 percentage change (%)
Standard Deviation 4.02031
|
1.9476 percentage change (%)
Standard Deviation 3.86739
|
—
|
SECONDARY outcome
Timeframe: baseline (screening), Week 78Population: The FAS-TP II subset was defined as all participants in FAS who received 1 full dose of the study drug (CT-P41 or US-licensed Prolia) at Week 52. The overall number of participants analyzed row represents the total number of participants in the FAS-TP II subset. The number analyzed per row represents the number of participants in FAS-TP II subset with lumbar spine, total hip, or femoral neck BMD value at baseline and Week 78.
Bone mineral density was assessed by DXA and assessments of the lumbar spine (L1 to L4), total hip, and femoral neck BMD were performed at a central imaging vendor.
Outcome measures
| Measure |
CT-P41
n=220 Participants
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=100 Participants
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
Switched to CT-P41
n=101 Participants
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|
|
Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 78 - FAS-TP II Subset
Total hip
|
3.4706 percentage change (%)
Standard Deviation 2.81017
|
2.7947 percentage change (%)
Standard Deviation 2.79862
|
3.3837 percentage change (%)
Standard Deviation 2.92786
|
|
Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 78 - FAS-TP II Subset
Femoral neck
|
2.9995 percentage change (%)
Standard Deviation 3.73072
|
2.4429 percentage change (%)
Standard Deviation 3.61786
|
2.8226 percentage change (%)
Standard Deviation 4.02021
|
|
Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 78 - FAS-TP II Subset
Lumbar spine
|
6.8588 percentage change (%)
Standard Deviation 4.12795
|
6.5745 percentage change (%)
Standard Deviation 3.40437
|
7.0532 percentage change (%)
Standard Deviation 3.55985
|
SECONDARY outcome
Timeframe: up to Week 52 predosePopulation: The overall number of participants analyzed and the number analyzed represents the total number of participants in FAS.
Efficacy analysis of new vertebral fractures included only vertebral fractures occurring from T4 to L4 and confirmed by the central imaging vendor. A new vertebral fracture was defined as an increase of ≥1 grade in any vertebra from T4 to L4 that was normal at screening. The nonvertebral fractures endpoint included fractures other than those of the vertebrae, excluding the skull, facial bones, mandible, metacarpals, and phalanges (fingers or toes) since they are not associated with decreased BMD, and excluded pathologic fractures and those associated with severe trauma acquired from a fall (from a height higher than a stool, chair, or first rung of a ladder) or otherwise. Only nonvertebral fractures confirmed by the central imaging vendor were included in the efficacy analysis. The fractures occurring at the site of femur neck, femur intertrochanter, or femur subtrochanter were considered as a hip fracture.
Outcome measures
| Measure |
CT-P41
n=239 Participants
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=238 Participants
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
Switched to CT-P41
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|
|
Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP I - FAS
Nonvertebral fracture
|
2 Participants
|
4 Participants
|
—
|
|
Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP I - FAS
New vertebral fracture
|
1 Participants
|
1 Participants
|
—
|
|
Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP I - FAS
Hip fracture
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: from Week 52 to Week 78Population: The overall number of participants analyzed and the number analyzed represents the total number of participants in FAS-TP II subset.
Efficacy analysis of new vertebral fractures included only vertebral fractures occurring from T4 to L4 and confirmed by the central imaging vendor. A new vertebral fracture was defined as an increase of ≥1 grade in any vertebra from T4 to L4 that was normal at screening. The nonvertebral fractures endpoint included fractures other than those of the vertebrae, excluding the skull, facial bones, mandible, metacarpals, and phalanges (fingers or toes) since they are not associated with decreased BMD, and excluded pathologic fractures and those associated with severe trauma acquired from a fall (from a height higher than a stool, chair, or first rung of a ladder) or otherwise. Only nonvertebral fractures confirmed by the central imaging vendor were included in the efficacy analysis. The fractures occurring at the site of femur neck, femur intertrochanter, or femur subtrochanter were considered as a hip fracture.
Outcome measures
| Measure |
CT-P41
n=220 Participants
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=100 Participants
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
Switched to CT-P41
n=101 Participants
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|
|
Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP II - FAS-TP II Subset
New vertebral fracture
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP II - FAS-TP II Subset
Nonvertebral fracture
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP II - FAS-TP II Subset
Hip fracture
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0 Day 1 predose, Week 26 predosePopulation: The PK Set was defined as all participants who received at least 1 full dose of the study drug (CT-P41 or US-licensed Prolia) and had at least 1 post-treatment PK concentration data with a concentration above the LLoQ prior to dosing at Week 52. The overall number of participants analyzed row represents the total number of participants in PK Set. The number analyzed per row represents the number of participants in PK set with data at the corresponding time point.
The Ctrough, a concentration before the next study drug administration, was calculated by non-compartmental analysis method from the concentration-time data. All serum concentrations below the lower limit of quantification (LLoQ) was set to 0 in the descriptive summaries of PK parameter estimation. In TP I, the Ctrough of denosumab at Weeks 0 and 26 was assessed as the serum concentration at Weeks 26 and 52 before the study drug administration, respectively.
Outcome measures
| Measure |
CT-P41
n=237 Participants
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=236 Participants
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
Switched to CT-P41
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|
|
Trough Serum Concentration (Ctrough) of Denosumab at Weeks 0 and 26 - Pharmacokinetic (PK) Set
Week 0 Day 1
|
46.79 ng/mL
Standard Deviation 105.102
|
31.69 ng/mL
Standard Deviation 73.253
|
—
|
|
Trough Serum Concentration (Ctrough) of Denosumab at Weeks 0 and 26 - Pharmacokinetic (PK) Set
Week 26
|
75.64 ng/mL
Standard Deviation 154.630
|
63.99 ng/mL
Standard Deviation 140.912
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: The PK-TP II subset was defined as all participants in the PK set who received 1 full dose of the study drug (CT-P41 or US-licensed Prolia) at Week 52 and had at least 1 post-treatment PK concentration data with a concentration above the LLoQ after Week 52. The overall number of participants analyzed row represents the number of participants in the PK-TP II subset who had the Ctrough data at Week 52.
The Ctrough, a concentration before the next study drug administration, was calculated by non-compartmental analysis method from the concentration-time data. All serum concentrations below the LLoQ was set to 0 in the descriptive summaries of PK parameter estimation. In TP II, the Ctrough of denosumab at Week 52 was assessed as the serum concentration at Week 78.
Outcome measures
| Measure |
CT-P41
n=214 Participants
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=96 Participants
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
Switched to CT-P41
n=98 Participants
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|
|
Ctrough of Denosumab at Week 52 - PK-TP II Subset
|
70.24 ng/mL
Standard Deviation 126.852
|
66.60 ng/mL
Standard Deviation 129.573
|
126.15 ng/mL
Standard Deviation 508.689
|
SECONDARY outcome
Timeframe: from baseline (Week 0 Day 1 predose) to Week 26 predosePopulation: Participants in the PK Set who had assessments of Cmax.
Cmax was calculated by non-compartmental analysis method from the concentration-time data. All serum concentrations below the LLoQ was set to 0 in the descriptive summaries of PK parameter estimation.
Outcome measures
| Measure |
CT-P41
n=237 Participants
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=236 Participants
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
Switched to CT-P41
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Denosumab After First Dose - PK Set
|
5851.2 ng/mL
Geometric Coefficient of Variation 32.2
|
5492.7 ng/mL
Geometric Coefficient of Variation 29.8
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0 Day 1 predose), Weeks 26 and 52 (predose)Population: The PD set was defined as all participants who received a full dose of the study drug (CT-P41 or US-licensed Prolia) at Day 1 (Week 0) and had at least 1 post-treatment PD concentration data with a concentration above the LLoQ before dosing at Week 52. The overall number of participants analyzed represents the total number of participants in PD set. The number analyzed per row represents the number of participants in the PD set who had the data at the corresponding time point.
Serum concentration below the LLoQ was set to the LLoQ. The percent change from baseline for serum concentration at each visit was calculated as (\[Result at each visit - Result at Baseline\] / Result at Baseline) × 100.
Outcome measures
| Measure |
CT-P41
n=237 Participants
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=236 Participants
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
Switched to CT-P41
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|
|
Percent Change From Baseline for Serum Concentration of Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Weeks 26 and 52 - Pharmacodynamic (PD) Set
Week 26
|
-75.6972 percentage change (%)
Interval -83.7838 to -59.8504
|
-74.3547 percentage change (%)
Interval -81.8667 to -63.0572
|
—
|
|
Percent Change From Baseline for Serum Concentration of Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Weeks 26 and 52 - Pharmacodynamic (PD) Set
Week 52
|
-72.7506 percentage change (%)
Interval -85.8306 to -57.1429
|
-72.5275 percentage change (%)
Interval -82.8794 to -56.6188
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0 Day 1 predose), Week 78Population: The PD-TP II subset was defined as all participants in the PD set who received 1 full dose of the study drug (CT-P41 or US-licensed Prolia) at Week 52 and had at least 1 post-treatment PD concentration data with a concentration above the LLoQ after Week 52. The overall number of participants analyzed represents the number of participants in the PD-TP II subset who had s-CTX value at baseline and Week 78.
Serum concentration below the LLoQ was set to the LLoQ. The percent change from baseline for serum concentration at each visit was calculated as (\[Result at each visit - Result at Baseline\] / Result at Baseline) × 100.
Outcome measures
| Measure |
CT-P41
n=214 Participants
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=97 Participants
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
Switched to CT-P41
n=98 Participants
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|
|
Percent Change From Baseline for Serum Concentration of s-CTX at Week 78 - PD-TP II Subset
|
-70.4609 percentage change (%)
Interval -81.068 to -46.4052
|
-64.9063 percentage change (%)
Interval -78.9644 to -48.6034
|
-70.1268 percentage change (%)
Interval -84.3162 to -47.494
|
SECONDARY outcome
Timeframe: Baseline (Week 0 Day 1 predose), Weeks 26 and 52 (predose)Population: The overall number of participants analyzed represents the total number of participants in PD Set. The number analyzed per row represents the number of participants in PD set who had P1NP value at the corresponding time point.
Serum concentration below the LLoQ was set to the LLoQ. The percent change from baseline for serum concentration at each visit was calculated as (\[Result at each visit - Result at Baseline\] / Result at Baseline) × 100.
Outcome measures
| Measure |
CT-P41
n=237 Participants
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=236 Participants
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
Switched to CT-P41
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|
|
Percent Change From Baseline for Serum Concentration of Procollagen Type 1 N-terminal Propeptide (P1NP) at Weeks 26 and 52 - PD Set
Week 52
|
-69.99 percentage change (%)
Interval -76.77 to -50.26
|
-66.61 percentage change (%)
Interval -76.56 to -53.16
|
—
|
|
Percent Change From Baseline for Serum Concentration of Procollagen Type 1 N-terminal Propeptide (P1NP) at Weeks 26 and 52 - PD Set
Week 26
|
-69.31 percentage change (%)
Interval -76.69 to -57.78
|
-68.22 percentage change (%)
Interval -76.79 to -56.68
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0 Day 1 predose), Week 78Population: The overall number of participants analyzed represents the number of participants in the PD-TP II subset who had the P1NP value at baseline and Week 78.
Serum concentration below the LLoQ was set to the LLoQ. The percent change from baseline for serum concentration was calculated as (\[Result at each visit - Result at Baseline\] / Result at Baseline) × 100.
Outcome measures
| Measure |
CT-P41
n=214 Participants
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=97 Participants
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
Switched to CT-P41
n=98 Participants
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|
|
Percent Change From Baseline for Serum Concentration of P1NP at Week 78 - PD-TP II Subset
|
-67.05 percentage change (%)
Interval -76.2 to -53.24
|
-68.60 percentage change (%)
Interval -75.12 to -50.11
|
-64.54 percentage change (%)
Interval -78.0 to -53.92
|
SECONDARY outcome
Timeframe: up to Week 52 predosePopulation: The Safety set was defined as all participants who received at least 1 dose (full or partial) of the study drug (CT-P41 or US-licensed Prolia). The overall number of participants analyzed and the number analyzed represents the total number of participants in the Safety Set.
Samples that were positive in the ADA confirmatory assay were analyzed further to conduct a NAb assessment. The test outcomes for the screening assay were 'Positive' or 'Negative'. The number of patients with at least one ADA/NAb positive result after the first study drug administration of each treatment period including scheduled and unscheduled visits (Treatment Period I: Week 0 / Treatment Period II: Week 52) regardless of their ADA status at baseline were presented.
Outcome measures
| Measure |
CT-P41
n=239 Participants
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=238 Participants
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
Switched to CT-P41
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|
|
Number of Participants With at Least 1 Anti-drug Antibodies (ADA)/Neutralizing Antibodies (NAb) Result After the First Study Drug Administration of TP I - Safety Set
ADA positive
|
233 Participants
|
234 Participants
|
—
|
|
Number of Participants With at Least 1 Anti-drug Antibodies (ADA)/Neutralizing Antibodies (NAb) Result After the First Study Drug Administration of TP I - Safety Set
NAb positive
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: from Week 52 to Week 78Population: The Safety-TP II subset was defined as all participants in the Safety set who received 1 dose (full or partial) of study drug (CT-P41 or US-licensed Prolia) at Week 52. The overall number of participants analyzed and the number analyzed represents the number of participants in the Safety-TP II subset.
Samples that were positive in the ADA confirmatory assay were analyzed further to conduct a NAb assessment. The test outcomes for the screening assay were 'Positive' or 'Negative'. The number of patients with at least one ADA/NAb positive result after the first study drug administration of each treatment period including scheduled and unscheduled visits (Treatment Period I: Week 0 / Treatment Period II: Week 52) regardless of their ADA status at baseline were presented.
Outcome measures
| Measure |
CT-P41
n=220 Participants
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=100 Participants
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
Switched to CT-P41
n=101 Participants
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|
|
Number of Participants With at Least 1 ADA/NAb Result After the First Study Drug Administration of TP II - Safety-TP II Subset
ADA positive
|
208 Participants
|
92 Participants
|
93 Participants
|
|
Number of Participants With at Least 1 ADA/NAb Result After the First Study Drug Administration of TP II - Safety-TP II Subset
NAb positive
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
CT-P41
Serious events: 7 serious events
Other events: 98 other events
Deaths: 1 deaths
US-licensed Prolia
Serious events: 10 serious events
Other events: 86 other events
Deaths: 0 deaths
CT-P41 Maintenance
Serious events: 8 serious events
Other events: 44 other events
Deaths: 1 deaths
US-licensed Prolia Maintenance
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Switched to CT-P41
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CT-P41
n=239 participants at risk
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=238 participants at risk
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
CT-P41 Maintenance
n=220 participants at risk
Participants treated with CT-P41 in TP I continued the treatment with CT-P41 as a third dose at Week 52 in TP II
|
US-licensed Prolia Maintenance
n=100 participants at risk
Participants treated with US-licensed Prolia in TP I were re-randomized to continue the treatment with US-licensed Prolia as a third dose at Week 52 in TP II
|
Switched to CT-P41
n=101 participants at risk
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
0.42%
1/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.42%
1/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.42%
1/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.42%
1/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.42%
1/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.45%
1/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Infections and infestations
COVID-19
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.42%
1/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Eye disorders
Cataract
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
1.0%
1/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.91%
2/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.45%
1/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.42%
1/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.45%
1/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Cardiac disorders
Coronary artery disease
|
0.42%
1/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.42%
1/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.42%
1/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Investigations
Hormone level abnormal
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
1.0%
1/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.42%
1/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.42%
1/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.45%
1/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.42%
1/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Borderline ovarian tumour
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.42%
1/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.42%
1/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.42%
1/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of adrenal gland
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
1.0%
1/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.45%
1/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Genital neoplasm malignant female
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.45%
1/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.45%
1/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.42%
1/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.42%
1/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Reproductive system and breast disorders
Vulval leukoplakia
|
0.42%
1/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.42%
1/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
1.0%
1/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.42%
1/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
Other adverse events
| Measure |
CT-P41
n=239 participants at risk
A total of 2 subcutaneous administration of 60 mg CT-P41 (proposed denosumab biosimilar) at Week 0 and Week 26 (26-week intervals) in TP I
CT-P41: 60 mg/mL single dose, Solution for injection in PFS
|
US-licensed Prolia
n=238 participants at risk
A total of 2 subcutaneous administration of 60 mg US-licensed Prolia (denosumab) at Week 0 and Week 26 (26-week intervals) in TP I
US-licensed Prolia: 60 mg/mL single dose, Solution for injection in PFS
|
CT-P41 Maintenance
n=220 participants at risk
Participants treated with CT-P41 in TP I continued the treatment with CT-P41 as a third dose at Week 52 in TP II
|
US-licensed Prolia Maintenance
n=100 participants at risk
Participants treated with US-licensed Prolia in TP I were re-randomized to continue the treatment with US-licensed Prolia as a third dose at Week 52 in TP II
|
Switched to CT-P41
n=101 participants at risk
Participants treated with US-licensed Prolia in TP I were re-randomized to switch to CT-P41 as a third dose at Week 52 in TP II
|
|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
11.7%
28/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
10.9%
26/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
3.6%
8/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
3.0%
3/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
5.9%
6/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.5%
25/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
8.4%
20/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
5.9%
13/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
4.0%
4/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
10.9%
11/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
12/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
1.7%
4/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
2.7%
6/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
3.0%
3/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
10/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
5.0%
12/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
1.8%
4/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
3.0%
3/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
4.0%
4/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
24/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
8.8%
21/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
3.2%
7/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.00%
0/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.99%
1/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.8%
9/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
5.5%
13/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
0.91%
2/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
1.0%
1/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
2.0%
2/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
6.3%
15/239 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
2.1%
5/238 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
2.7%
6/220 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
3.0%
3/100 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
4.0%
4/101 • Through Week 78 - Treatment Period I: Adverse event start date before the study drug administration in Treatment Period II - Treatment Period II: Adverse event start date on or after the date of study drug administration in Treatment Period II.
Among the 240 in the CT-P41 group and 239 in the US-licensed Prolia group who initiated Treatment Period I, one participant each terminated the study participation before the first study treatment administration. Since the adverse events results in Treatment Period I was summarized in the safety set who received at least 1 dose of the study drug during Treatment Period I, the total number of participants at risk was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively.
|
Additional Information
Head of Clinical Planning Department
CELLTRION, Inc.
Phone: +82 32 850 4167
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER