Trial Outcomes & Findings for A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis (NCT NCT05067335)
NCT ID: NCT05067335
Last Updated: 2024-12-05
Results Overview
Percent change from baseline in BMD at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA) at 6 months. Missing postbaseline BMD other than due to COVID-19 were imputed using the last observation carried forward (LOCF) approach. Missing or out of window (exceed 70 days since previous IMP) post-baseline DXA BMD due to COVID-19 were set to missing and imputed by multiple imputation under missing at random approach. LSM = least square mean.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
327 participants
Primary outcome timeframe
From Baseline (Day 1) to the end of the Double-blind Period (Month 6)
Results posted on
2024-12-05
Participant Flow
The study started to enroll participants in October 2021 and concluded in November 2023.
Participant flow refers to the Randomized Set.
Participant milestones
| Measure |
Placebo
Participants randomized to this arm received a matching placebo subcutaneously (sc) every month (QM) during the 6-month Double-blind (DB) Period.
|
Romosozumab
Participants randomized to this arm received romosozumab (Romo) 210 milligrams (mg) sc QM during the 6-month Double-blind Period.
|
Placebo/Romosozumab
After completion of the 6-month Double-blind Period, participants initially randomized to placebo arm switched to receive romosozumab 210 mg sc QM during the 6-month Open-label (OL) Period (up to Month 12).
|
Romosozumab/Romosozumab
After completion of the 6-month Double-blind Period, participants initially randomized to romosozumab arm continued to receive romosozumab 210 mg sc QM during the Open-label Period (up to Month 12).
|
|---|---|---|---|---|
|
Double-blind Period: Day 1 - Month 6
STARTED
|
109
|
218
|
0
|
0
|
|
Double-blind Period: Day 1 - Month 6
COMPLETED
|
100
|
204
|
0
|
0
|
|
Double-blind Period: Day 1 - Month 6
NOT COMPLETED
|
9
|
14
|
0
|
0
|
|
Open-label Period: Month 7 - 12
STARTED
|
0
|
0
|
99
|
204
|
|
Open-label Period: Month 7 - 12
COMPLETED
|
0
|
0
|
93
|
199
|
|
Open-label Period: Month 7 - 12
NOT COMPLETED
|
0
|
0
|
6
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Participants randomized to this arm received a matching placebo subcutaneously (sc) every month (QM) during the 6-month Double-blind (DB) Period.
|
Romosozumab
Participants randomized to this arm received romosozumab (Romo) 210 milligrams (mg) sc QM during the 6-month Double-blind Period.
|
Placebo/Romosozumab
After completion of the 6-month Double-blind Period, participants initially randomized to placebo arm switched to receive romosozumab 210 mg sc QM during the 6-month Open-label (OL) Period (up to Month 12).
|
Romosozumab/Romosozumab
After completion of the 6-month Double-blind Period, participants initially randomized to romosozumab arm continued to receive romosozumab 210 mg sc QM during the Open-label Period (up to Month 12).
|
|---|---|---|---|---|
|
Double-blind Period: Day 1 - Month 6
Adverse Event
|
1
|
2
|
0
|
0
|
|
Double-blind Period: Day 1 - Month 6
Protocol Violation
|
1
|
1
|
0
|
0
|
|
Double-blind Period: Day 1 - Month 6
Withdrawal by Subject
|
6
|
10
|
0
|
0
|
|
Double-blind Period: Day 1 - Month 6
Patient Voluntary Withdrawal
|
1
|
0
|
0
|
0
|
|
Double-blind Period: Day 1 - Month 6
The Patient Withdrew Early Due To Their Own Reasons
|
0
|
1
|
0
|
0
|
|
Open-label Period: Month 7 - 12
Adverse Event
|
0
|
0
|
3
|
2
|
|
Open-label Period: Month 7 - 12
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Open-label Period: Month 7 - 12
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
|
Open-label Period: Month 7 - 12
Subject Was Unable To Comply With Study Procedures Due To Prolonged Withdrawal From Medication
|
0
|
0
|
1
|
0
|
|
Open-label Period: Month 7 - 12
Did not receive Open-label IMP at Month 6 and then discontinued
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis
Baseline characteristics by cohort
| Measure |
Placebo
n=109 Participants
Participants randomized to this arm received a matching placebo subcutaneously (sc) every month (QM) during the 6-month Double-blind (DB) Period.
|
Romosozumab
n=218 Participants
Participants randomized to this arm received romosozumab (Romo) 210 milligrams (mg) sc QM during the 6-month Double-blind Period.
|
Total
n=327 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.3 Years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
67.0 Years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
67.1 Years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Age, Customized
18 - <65 yrs
|
31 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Age, Customized
65 - <85 yrs
|
76 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Age, Customized
>=85 yrs
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
327 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
Asian
|
109 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
327 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
109 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
327 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) to the end of the Double-blind Period (Month 6)Population: The Full Analysis Set (FAS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and provided at least 1 Baseline and post-Baseline BMD measurement.
Percent change from baseline in BMD at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA) at 6 months. Missing postbaseline BMD other than due to COVID-19 were imputed using the last observation carried forward (LOCF) approach. Missing or out of window (exceed 70 days since previous IMP) post-baseline DXA BMD due to COVID-19 were set to missing and imputed by multiple imputation under missing at random approach. LSM = least square mean.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants randomized to this arm received a matching placebo subcutaneously (sc) every month (QM) during the 6-month Double-blind (DB) Period.
|
Romosozumab
n=214 Participants
Participants randomized to this arm received romosozumab (Romo) 210 milligrams (mg) sc QM during the 6-month Double-blind Period.
|
|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine to the End of Double-Blind Period
|
0.44 percent change
Standard Error 0.442
|
9.81 percent change
Standard Error 0.323
|
PRIMARY outcome
Timeframe: From Baseline to the end of the Double-blind Period (Month 6)Population: The Safety Set (SS) consisted of all randomized study participants who received at least 1 dose of IMP.
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a IMP, whether or not related to the IMP. TEAEs are defined as all AEs started on or worsened in severity on or after the date of receiving first dose of IMP and before or on the end of study (EOS) date.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants randomized to this arm received a matching placebo subcutaneously (sc) every month (QM) during the 6-month Double-blind (DB) Period.
|
Romosozumab
n=218 Participants
Participants randomized to this arm received romosozumab (Romo) 210 milligrams (mg) sc QM during the 6-month Double-blind Period.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period
|
70.6 percentage of participants
|
72.9 percentage of participants
|
PRIMARY outcome
Timeframe: From Month 7 up to Month 12 (Placebo/Romo) and From Day 1 up to Month 12 (Romo/Romo) + 3-month SFU (up to Month 15)Population: The SS consisted of all randomized study participants who received at least 1 dose of IMP. The SS for open label period consisted of all randomized study participants who received at least 1 dose of IMP during open label period.
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a IMP, whether or not related to IMP. TEAEs are defined as all AEs started on or worsened in severity on or after date of receiving first dose of IMP and before or on EOS date except lipid-type AEs starting on date of first dose of IMP and not worsening (and not deemed IMP related by the investigator). As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romosozumab arm (Open-label Period) and for a total of 12 months for participants in romosozumab/romosozumab arm (Double-blind Period + Open-label Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during overall period.
Outcome measures
| Measure |
Placebo
n=98 Participants
Participants randomized to this arm received a matching placebo subcutaneously (sc) every month (QM) during the 6-month Double-blind (DB) Period.
|
Romosozumab
n=218 Participants
Participants randomized to this arm received romosozumab (Romo) 210 milligrams (mg) sc QM during the 6-month Double-blind Period.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events for Romosozumab During Overall Period
|
80.6 percentage of participants
|
88.1 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to the end of the Double-blind Period (Month 6)Population: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and provided at least 1 Baseline and post-Baseline BMD measurement.
Percent change from baseline in BMD at the total hip was assessed by DXA at 6 months. Missing postbaseline BMD other than due to COVID-19 were imputed using the LOCF approach. Missing or out of window (exceed 70 days since previous IMP) post-baseline DXA BMD due to COVID-19 were set to missing and imputed by multiple imputation under missing at random approach.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants randomized to this arm received a matching placebo subcutaneously (sc) every month (QM) during the 6-month Double-blind (DB) Period.
|
Romosozumab
n=214 Participants
Participants randomized to this arm received romosozumab (Romo) 210 milligrams (mg) sc QM during the 6-month Double-blind Period.
|
|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density at the Total Hip to the End of Double-Blind Period
|
0.07 percent change
Standard Error 0.285
|
2.93 percent change
Standard Error 0.206
|
SECONDARY outcome
Timeframe: From Baseline to the end of the Double-blind Period (Month 6)Population: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and provided at least 1 Baseline and post-Baseline BMD measurement.
Percent change from baseline in BMD at the femoral neck was assessed by DXA at 6 months. Missing postbaseline BMD other than due to COVID-19 were imputed using the LOCF approach. Missing or out of window (exceed 70 days since previous IMP) post-baseline DXA BMD due to COVID-19 were set to missing and imputed by multiple imputation under missing at random approach.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants randomized to this arm received a matching placebo subcutaneously (sc) every month (QM) during the 6-month Double-blind (DB) Period.
|
Romosozumab
n=214 Participants
Participants randomized to this arm received romosozumab (Romo) 210 milligrams (mg) sc QM during the 6-month Double-blind Period.
|
|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density at the Femoral Neck to the End of the Double-Blind Period
|
-0.15 percent change
Standard Error 0.406
|
3.33 percent change
Standard Error 0.347
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and provided at least 1 Baseline and post-Baseline BMD measurement.
Percent change from Baseline in BMD at the lumbar spine was assessed by DXA at 12 months. Missing postbaseline BMD other than due to COVID-19 were imputed using the LOCF approach. Missing or out of window (exceed 70 days since previous IMP) post-baseline DXA BMD due to COVID-19 were set to missing and imputed by multiple imputation under missing at random approach. For Placebo/Romosozumab Treatment group, only the post Month 6 value was used for imputation for Open-label Period, the values in the Double-blind Period were not carried forward into the Open-label Period.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants randomized to this arm received a matching placebo subcutaneously (sc) every month (QM) during the 6-month Double-blind (DB) Period.
|
Romosozumab
n=214 Participants
Participants randomized to this arm received romosozumab (Romo) 210 milligrams (mg) sc QM during the 6-month Double-blind Period.
|
|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12
|
8.80 percent change
Standard Error 0.554
|
13.04 percent change
Standard Error 0.389
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and provided at least 1 Baseline and post-Baseline BMD measurement.
Percent change from Baseline in BMD at the total hip was assessed by DXA at 12 months. Missing postbaseline BMD other than due to COVID-19 were imputed using the LOCF approach. Missing or out of window (exceed 70 days since previous IMP) post-baseline DXA BMD due to COVID-19 were set to missing and imputed by multiple imputation under missing at random approach. For Placebo/Romosozumab Treatment group, only the post Month 6 value was used for imputation for Open-label Period, the values in the Double-blind Period were not carried forward into the Open-label Period.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants randomized to this arm received a matching placebo subcutaneously (sc) every month (QM) during the 6-month Double-blind (DB) Period.
|
Romosozumab
n=214 Participants
Participants randomized to this arm received romosozumab (Romo) 210 milligrams (mg) sc QM during the 6-month Double-blind Period.
|
|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12
|
1.83 percent change
Standard Error 0.306
|
4.22 percent change
Standard Error 0.216
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: The FAS consisted of all randomized study participants who received at least 1 dose of IMP and provided at least 1 Baseline and post-Baseline BMD measurement.
Percent change from Baseline in BMD at the femoral neck was assessed by DXA at 12 months. Missing postbaseline BMD other than due to COVID-19 were imputed using the LOCF approach. Missing or out of window (exceed 70 days since previous IMP) post-baseline DXA BMD due to COVID-19 were set to missing and imputed by multiple imputation under missing at random approach. For Placebo/Romosozumab Treatment group, only the post Month 6 value was used for imputation for Open-label Period, the values in the Double-blind Period were not carried forward into the Open-label Period.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants randomized to this arm received a matching placebo subcutaneously (sc) every month (QM) during the 6-month Double-blind (DB) Period.
|
Romosozumab
n=214 Participants
Participants randomized to this arm received romosozumab (Romo) 210 milligrams (mg) sc QM during the 6-month Double-blind Period.
|
|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12
|
1.87 percent change
Standard Error 0.441
|
4.66 percent change
Standard Error 0.371
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Romosozumab
Serious events: 8 serious events
Other events: 59 other events
Deaths: 0 deaths
Placebo/Romosozumab
Serious events: 9 serious events
Other events: 59 other events
Deaths: 0 deaths
Romosozumab/Romosozumab Overall
Serious events: 25 serious events
Other events: 155 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=109 participants at risk
Participants randomized to this arm received a matching placebo subcutaneously (sc) every month (QM) during the 6-month Double-blind (DB) Period.
|
Romosozumab
n=218 participants at risk
Participants randomized to this arm received romosozumab (Romo) 210 milligrams (mg) sc QM during the 6-month Double-blind Period.
|
Placebo/Romosozumab
n=98 participants at risk
After completion of the 6-month Double-blind Period, participants initially randomized to placebo arm switched to receive romosozumab 210 mg sc QM during the 6-month Open-label (OL) Period (up to Month 12).
|
Romosozumab/Romosozumab Overall
n=218 participants at risk
Participants who received romosozumab 210 mg sc QM during the 6-month Double-blind Period and continued to receive romosozumab 210 mg sc QM during the 6-month Open-label Period.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Cardiac disorders
Atrial fibrillation
|
0.92%
1/109 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Eye disorders
Cataract
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.92%
2/218 • Number of events 2 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.92%
2/218 • Number of events 2 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Infections and infestations
Herpes zoster
|
0.92%
1/109 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.92%
1/109 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Nervous system disorders
Cerebral infarction
|
0.92%
1/109 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Vascular disorders
Hypertension
|
0.92%
1/109 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
General disorders
Granuloma
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
1.0%
1/98 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Infections and infestations
Otitis media
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
1.0%
1/98 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
1.0%
1/98 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
1.0%
1/98 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Bone hypertrophy
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 2 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
1.0%
1/98 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
1.0%
1/98 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.92%
2/218 • Number of events 2 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
1.0%
1/98 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
1.0%
1/98 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
1.0%
1/98 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
1.0%
1/98 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/109 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/218 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.00%
0/98 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
0.46%
1/218 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
Other adverse events
| Measure |
Placebo
n=109 participants at risk
Participants randomized to this arm received a matching placebo subcutaneously (sc) every month (QM) during the 6-month Double-blind (DB) Period.
|
Romosozumab
n=218 participants at risk
Participants randomized to this arm received romosozumab (Romo) 210 milligrams (mg) sc QM during the 6-month Double-blind Period.
|
Placebo/Romosozumab
n=98 participants at risk
After completion of the 6-month Double-blind Period, participants initially randomized to placebo arm switched to receive romosozumab 210 mg sc QM during the 6-month Open-label (OL) Period (up to Month 12).
|
Romosozumab/Romosozumab Overall
n=218 participants at risk
Participants who received romosozumab 210 mg sc QM during the 6-month Double-blind Period and continued to receive romosozumab 210 mg sc QM during the 6-month Open-label Period.
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
11.0%
12/109 • Number of events 12 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
6.9%
15/218 • Number of events 15 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
22.4%
22/98 • Number of events 22 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
22.5%
49/218 • Number of events 50 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.6%
5/109 • Number of events 5 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
6.0%
13/218 • Number of events 16 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
6.1%
6/98 • Number of events 8 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
13.8%
30/218 • Number of events 37 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Infections and infestations
Suspected COVID-19
|
3.7%
4/109 • Number of events 4 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
5.0%
11/218 • Number of events 11 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
14.3%
14/98 • Number of events 14 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
19.7%
43/218 • Number of events 43 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.6%
5/109 • Number of events 5 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
5.0%
11/218 • Number of events 13 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
1.0%
1/98 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
10.1%
22/218 • Number of events 25 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
General disorders
Pyrexia
|
0.92%
1/109 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
1.4%
3/218 • Number of events 3 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
6.1%
6/98 • Number of events 6 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
7.3%
16/218 • Number of events 16 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Infections and infestations
Nasopharyngitis
|
0.92%
1/109 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
3.7%
8/218 • Number of events 8 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
2.0%
2/98 • Number of events 3 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
5.0%
11/218 • Number of events 12 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Investigations
SARS-CoV-2 test positive
|
0.92%
1/109 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
1.4%
3/218 • Number of events 3 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
3.1%
3/98 • Number of events 3 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
5.5%
12/218 • Number of events 12 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.8%
2/109 • Number of events 2 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
4.1%
9/218 • Number of events 9 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
4.1%
4/98 • Number of events 4 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
5.5%
12/218 • Number of events 12 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
General disorders
Injection site reaction
|
0.92%
1/109 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
8.7%
19/218 • Number of events 27 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
6.1%
6/98 • Number of events 9 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
9.2%
20/218 • Number of events 30 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
3/109 • Number of events 3 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
3.7%
8/218 • Number of events 9 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
1.0%
1/98 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
7.3%
16/218 • Number of events 18 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.92%
1/109 • Number of events 1 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
2.8%
6/218 • Number of events 6 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
12.2%
12/98 • Number of events 12 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
8.7%
19/218 • Number of events 20 • From Baseline to Safety Follow Up (up to Month 15)
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60