Trial Outcomes & Findings for Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II) (NCT NCT02023879)
NCT ID: NCT02023879
Last Updated: 2018-07-27
Results Overview
Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
233 participants
Primary outcome timeframe
From Baseline to Week 24
Results posted on
2018-07-27
Participant Flow
The study was conducted at 43 centers in 8 countries. A total of 402 participants were screened between December-2013 and May-2014, of whom 233 were randomized for double-blind (DB) treatment period and 169 were screen failures. Out of 233 randomized for DB period, 205 participants entered the optional open-label (OL) extension period.
Randomization was stratified by statin intolerant status \& background therapy (non-statin lipid therapy vs diet). Randomization followed a 1:2:1 ratio for placebo, Alirocumab 75 mg and Alirocumab 150 mg instead of 1:1:2 as initially planned due to systematic error in treatment allocation algorithm discovered after all participants were randomized.
Participant milestones
| Measure |
Placebo Q2W
Period 1: Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
Period 2: Alirocumab 150 mg SC injection every 4 weeks (Q4W) from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)
Period 1: Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Period 1: Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
|
|---|---|---|---|
|
Period 1: 24-Week Double-blind Treatment
STARTED
|
58
|
116
|
59
|
|
Period 1: 24-Week Double-blind Treatment
Treated
|
58
|
115
|
58
|
|
Period 1: 24-Week Double-blind Treatment
COMPLETED
|
54
|
107
|
50
|
|
Period 1: 24-Week Double-blind Treatment
NOT COMPLETED
|
4
|
9
|
9
|
|
Extension Open Label Treatment
STARTED
|
51
|
106
|
48
|
|
Extension Open Label Treatment
COMPLETED
|
46
|
89
|
43
|
|
Extension Open Label Treatment
NOT COMPLETED
|
5
|
17
|
5
|
Reasons for withdrawal
| Measure |
Placebo Q2W
Period 1: Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
Period 2: Alirocumab 150 mg SC injection every 4 weeks (Q4W) from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)
Period 1: Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Period 1: Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
|
|---|---|---|---|
|
Period 1: 24-Week Double-blind Treatment
Adverse Event
|
2
|
2
|
5
|
|
Period 1: 24-Week Double-blind Treatment
Poor compliance to protocol
|
0
|
2
|
1
|
|
Period 1: 24-Week Double-blind Treatment
Physician Decision
|
0
|
1
|
0
|
|
Period 1: 24-Week Double-blind Treatment
Consent withdrawn by participant
|
1
|
0
|
1
|
|
Period 1: 24-Week Double-blind Treatment
Randomized but not treated
|
0
|
1
|
1
|
|
Period 1: 24-Week Double-blind Treatment
Other than specified above
|
1
|
3
|
1
|
|
Extension Open Label Treatment
Adverse Event
|
1
|
7
|
3
|
|
Extension Open Label Treatment
Poor compliance to protocol
|
1
|
1
|
0
|
|
Extension Open Label Treatment
Participant moved
|
1
|
2
|
0
|
|
Extension Open Label Treatment
Other than specified above
|
2
|
7
|
2
|
Baseline Characteristics
Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)
Baseline characteristics by cohort
| Measure |
Placebo Q2W
n=58 Participants
Period 1: Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
Period 2: Alirocumab 150 mg SC injection every 4 weeks (Q4W) from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)
n=116 Participants
Period 1: Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=59 Participants
Period 1: Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
64.2 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
220 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
219 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Calculated LDL-C in mg/dL
|
158.5 mg/dL
STANDARD_DEVIATION 47.3 • n=5 Participants
|
154.5 mg/dL
STANDARD_DEVIATION 44.6 • n=7 Participants
|
163.9 mg/dL
STANDARD_DEVIATION 69.1 • n=5 Participants
|
157.9 mg/dL
STANDARD_DEVIATION 52.4 • n=4 Participants
|
|
Calculated LDL-C in mmol/L
|
4.106 mmol/L
STANDARD_DEVIATION 1.226 • n=5 Participants
|
4.002 mmol/L
STANDARD_DEVIATION 1.154 • n=7 Participants
|
4.245 mmol/L
STANDARD_DEVIATION 1.789 • n=5 Participants
|
4.089 mmol/L
STANDARD_DEVIATION 1.356 • n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 24Population: ITT population that included all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.
Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=57 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis)
|
-53.5 percent change
Standard Error 1.6
|
4.7 percent change
Standard Error 2.3
|
-51.7 percent change
Standard Error 2.3
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Modified ITT (mITT) population that included all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=56 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=57 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
|
-55.3 percent change
Standard Error 1.5
|
5.1 percent change
Standard Error 2.1
|
-54.6 percent change
Standard Error 2.1
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=57 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
|
-50.8 percent change
Standard Error 1.7
|
3.2 percent change
Standard Error 2.5
|
-41.7 percent change
Standard Error 2.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: mITT population.
Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=56 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=57 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
|
-51.5 percent change
Standard Error 1.6
|
3.6 percent change
Standard Error 2.3
|
-44.8 percent change
Standard Error 2.3
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=57 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C to Averaged Weeks 9 to 12 - ITT- Analysis
|
-53.6 percent change
Standard Error 1.4
|
3.2 percent change
Standard Error 2.0
|
-52.3 percent change
Standard Error 2.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: mITT population.
Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=56 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=57 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Averaged Week 9 to 12 - On-Treatment Analysis
|
-54.1 percent change
Standard Error 1.3
|
3.6 percent change
Standard Error 1.9
|
-55.0 percent change
Standard Error 1.9
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.
Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=112 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=56 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
|
-39.7 percent change
Standard Error 1.5
|
7.5 percent change
Standard Error 2.1
|
-38.9 percent change
Standard Error 2.2
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: mITT population. Number of participants analyzed = participants of the mITT population with available data at specified time-points.
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=112 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=54 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=54 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis
|
-41.2 percent change
Standard Error 1.4
|
7.7 percent change
Standard Error 2.0
|
-40.9 percent change
Standard Error 2.1
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=57 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at Week 24 - ITT Analysis
|
-45.3 percent change
Standard Error 1.5
|
4.8 percent change
Standard Error 2.1
|
-44.2 percent change
Standard Error 2.1
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: mITT population.
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=56 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=57 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis
|
-46.9 percent change
Standard Error 1.3
|
5.0 percent change
Standard Error 1.9
|
-46.7 percent change
Standard Error 1.9
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=57 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Total-C at Week 24 - ITT Analysis
|
-34.0 percent change
Standard Error 1.1
|
3.0 percent change
Standard Error 1.6
|
-32.3 percent change
Standard Error 1.6
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=112 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=56 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
|
-38.4 percent change
Standard Error 1.6
|
7.0 percent change
Standard Error 2.2
|
-31.3 percent change
Standard Error 2.2
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=57 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
|
-43.4 percent change
Standard Error 1.5
|
3.0 percent change
Standard Error 2.2
|
-34.9 percent change
Standard Error 2.2
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=57 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
|
-32.6 percent change
Standard Error 1.2
|
1.8 percent change
Standard Error 1.6
|
-24.5 percent change
Standard Error 1.6
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Moderate CV risk: 10-year fatal cardiovascular disease (CVD) risk Systemic Coronary Risk Evaluation (SCORE) ≥1 and \<5%. High CV risk: 10-year fatal CVD risk SCORE ≥5% or moderate chronic kidney disease or type 1 or type 2 diabetes mellitus without target organ damage or familial hypercholesterolemia. Very high CV risk: history of documented coronary heart disease, ischemic stroke, peripheral artery disease, transient ischemic attack, abdominal aortic aneurysm, or carotid artery occlusion \>50% without symptoms; carotid endarterectomy or carotid artery stent procedure; renal artery stenosis, or renal artery stent procedure; or type 1 or type 2 diabetes mellitus with target organ damage. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=57 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C <100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis
|
70.3 percentage of participants
|
1.8 percentage of participants
|
63.9 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: mITT population.
Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=56 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=57 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percentage of Very High CV Risk Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C< 100 mg/dL (<2.59 mmol/L) at Week 24 - On-treatment Analysis
|
72.7 percentage of participants
|
1.8 percentage of participants
|
67.7 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted percentages at Week 24 from last observation carried forward (LOCF) approach including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=57 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percentage of Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) at Week 24 - ITT Analysis
|
60.0 percentage of participants
|
0.0 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: mITT population.
Adjusted percentages at Week 24 from LOCF approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=56 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=57 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) at Week 24 - On-treatment Analysis
|
61.7 percentage of participants
|
0.0 percentage of participants
|
50.9 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=57 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis
|
-21.8 percent change
Standard Error 2.6
|
4.1 percent change
Standard Error 3.7
|
-15.5 percent change
Standard Error 3.7
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=57 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis
|
-16.5 percent change
Standard Error 2.4
|
2.2 percent change
Standard Error 3.4
|
-5.7 percent change
Standard Error 3.3
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=57 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
|
7.4 percent change
Standard Error 1.4
|
-2.4 percent change
Standard Error 1.9
|
7.7 percent change
Standard Error 2.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=57 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
|
6.8 percent change
Standard Error 1.3
|
-0.8 percent change
Standard Error 1.9
|
8.6 percent change
Standard Error 1.9
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=57 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
|
-10.6 percent change
Standard Error 2.7
|
1.1 percent change
Standard Error 3.8
|
-9.2 percent change
Standard Error 3.9
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=115 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=57 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
|
-11.3 percent change
Standard Error 2.7
|
2.1 percent change
Standard Error 3.9
|
-3.0 percent change
Standard Error 3.8
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.
Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=112 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=56 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis
|
8.2 percent change
Standard Error 1.1
|
3.4 percent change
Standard Error 1.5
|
10.0 percent change
Standard Error 1.5
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=112 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=56 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=58 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
|
5.9 percent change
Standard Error 1.1
|
2.6 percent change
Standard Error 1.5
|
7.6 percent change
Standard Error 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 32, 36, 48, 72, 96, 120, 144 and Week 168Population: Open-label extension population included all participants who received at least one dose or part of dose of Alirocumab during the open label extension period. Here, "number analyzed" signifies the number of participants evaluable for each specified time-point.
Mean percent changes (and standard deviations) observed during the open-label extension period are provided.
Outcome measures
| Measure |
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=106 Participants
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
Placebo Q2W
n=51 Participants
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
|
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
n=48 Participants
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
|
|---|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 32, 36, 48, 72, 96, 120, 144, 168 On-Treatment Analysis in Open Label Extension Treatment Phase
Week 32
|
-41.1 percent change
Standard Deviation 21.2
|
-37.3 percent change
Standard Deviation 18.8
|
-46.9 percent change
Standard Deviation 13.3
|
|
Percent Change From Baseline in Calculated LDL-C at Week 32, 36, 48, 72, 96, 120, 144, 168 On-Treatment Analysis in Open Label Extension Treatment Phase
Week 36
|
-39.2 percent change
Standard Deviation 21.2
|
-36.1 percent change
Standard Deviation 22.0
|
-43.1 percent change
Standard Deviation 13.7
|
|
Percent Change From Baseline in Calculated LDL-C at Week 32, 36, 48, 72, 96, 120, 144, 168 On-Treatment Analysis in Open Label Extension Treatment Phase
Week 48
|
-49.2 percent change
Standard Deviation 18.7
|
-46.5 percent change
Standard Deviation 24.2
|
-48.7 percent change
Standard Deviation 21.7
|
|
Percent Change From Baseline in Calculated LDL-C at Week 32, 36, 48, 72, 96, 120, 144, 168 On-Treatment Analysis in Open Label Extension Treatment Phase
Week 72
|
-53.7 percent change
Standard Deviation 19.5
|
-50.8 percent change
Standard Deviation 20.6
|
-52.3 percent change
Standard Deviation 21.3
|
|
Percent Change From Baseline in Calculated LDL-C at Week 32, 36, 48, 72, 96, 120, 144, 168 On-Treatment Analysis in Open Label Extension Treatment Phase
Week 96
|
-52.8 percent change
Standard Deviation 19.6
|
-49.8 percent change
Standard Deviation 20.4
|
-46.8 percent change
Standard Deviation 22.0
|
|
Percent Change From Baseline in Calculated LDL-C at Week 32, 36, 48, 72, 96, 120, 144, 168 On-Treatment Analysis in Open Label Extension Treatment Phase
Week 120
|
-53.7 percent change
Standard Deviation 18.7
|
-50.6 percent change
Standard Deviation 20.9
|
-51.8 percent change
Standard Deviation 24.1
|
|
Percent Change From Baseline in Calculated LDL-C at Week 32, 36, 48, 72, 96, 120, 144, 168 On-Treatment Analysis in Open Label Extension Treatment Phase
Week 144
|
-48.7 percent change
Standard Deviation 23.7
|
-52.7 percent change
Standard Deviation 17.6
|
-49.4 percent change
Standard Deviation 20.9
|
|
Percent Change From Baseline in Calculated LDL-C at Week 32, 36, 48, 72, 96, 120, 144, 168 On-Treatment Analysis in Open Label Extension Treatment Phase
Week 168
|
-66.2 percent change
Standard Deviation 17.1
|
-47.8 percent change
Standard Deviation 24.2
|
-60.0 percent change
Standard Deviation 4.6
|
Adverse Events
Placebo Q2W
Serious events: 4 serious events
Other events: 28 other events
Deaths: 0 deaths
Alirocumab 75 mg Q2W/Up150 mg Q2W
Serious events: 7 serious events
Other events: 61 other events
Deaths: 0 deaths
Alirocumab 150 mg Q4W/Up150 mg Q2W
Serious events: 7 serious events
Other events: 29 other events
Deaths: 0 deaths
Alirocumab 150 mg Q4W (After Placebo Q2W)
Serious events: 15 serious events
Other events: 42 other events
Deaths: 0 deaths
Alirocumab 150 mg Q4W (After Alirocumab 75 Q2W/Up150 Q2W)
Serious events: 28 serious events
Other events: 71 other events
Deaths: 2 deaths
Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up150 Q2W)
Serious events: 14 serious events
Other events: 31 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo Q2W
n=58 participants at risk
Participants exposed to placebo SC injection Q2W added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).
|
Alirocumab 75 mg Q2W/Up150 mg Q2W
n=115 participants at risk
Participants exposed to alirocumab 75 mg Q2W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).
|
Alirocumab 150 mg Q4W/Up150 mg Q2W
n=58 participants at risk
Participants exposed to alirocumab 150 mg Q4W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 22 weeks).
|
Alirocumab 150 mg Q4W (After Placebo Q2W)
n=51 participants at risk
Participants exposed to alirocumab 150 mg Q4W SC injection added to stable non-statin LMT or diet alone (mean exposure of 128 weeks) after having received Placebo Q2W for 24 weeks.
|
Alirocumab 150 mg Q4W (After Alirocumab 75 Q2W/Up150 Q2W)
n=106 participants at risk
Participants exposed to alirocumab 150 mg Q4W SC injection added to stable non-statin LMT or diet alone (mean exposure of 117 weeks) after having received Alirocumab 75 mg Q2W/Up to 150 mg Q2W for 24 weeks.
|
Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up150 Q2W)
n=48 participants at risk
Participants exposed to alirocumab 150 mg Q4W SC injection added to stable non-statin LMT or diet alone (mean exposure of 119 weeks) after having received Alirocumab 150 mg Q4W/Up to 150 mg Q2W for 24 weeks.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.8%
3/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.9%
2/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.9%
2/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Cardiac disorders
Mitral valve incompetence
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
General disorders
Chest pain
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.9%
2/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Infections and infestations
Device related infection
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Infections and infestations
Hepatitis E
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
4.2%
2/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
3.9%
2/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Traumatic renal injury
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.9%
2/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign fallopian tube neoplasm
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.9%
2/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Nervous system disorders
Arachnoiditis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.9%
2/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Nervous system disorders
Syncope
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.8%
3/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
4.2%
2/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Psychiatric disorders
Depression
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Vascular disorders
Haematoma
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Vascular disorders
Hypotension
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.9%
2/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
Other adverse events
| Measure |
Placebo Q2W
n=58 participants at risk
Participants exposed to placebo SC injection Q2W added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).
|
Alirocumab 75 mg Q2W/Up150 mg Q2W
n=115 participants at risk
Participants exposed to alirocumab 75 mg Q2W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).
|
Alirocumab 150 mg Q4W/Up150 mg Q2W
n=58 participants at risk
Participants exposed to alirocumab 150 mg Q4W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 22 weeks).
|
Alirocumab 150 mg Q4W (After Placebo Q2W)
n=51 participants at risk
Participants exposed to alirocumab 150 mg Q4W SC injection added to stable non-statin LMT or diet alone (mean exposure of 128 weeks) after having received Placebo Q2W for 24 weeks.
|
Alirocumab 150 mg Q4W (After Alirocumab 75 Q2W/Up150 Q2W)
n=106 participants at risk
Participants exposed to alirocumab 150 mg Q4W SC injection added to stable non-statin LMT or diet alone (mean exposure of 117 weeks) after having received Alirocumab 75 mg Q2W/Up to 150 mg Q2W for 24 weeks.
|
Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up150 Q2W)
n=48 participants at risk
Participants exposed to alirocumab 150 mg Q4W SC injection added to stable non-statin LMT or diet alone (mean exposure of 119 weeks) after having received Alirocumab 150 mg Q4W/Up to 150 mg Q2W for 24 weeks.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
2/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
4.3%
5/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.9%
3/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
10.4%
11/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
4.2%
2/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Gastrointestinal disorders
Nausea
|
3.4%
2/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.2%
6/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.2%
3/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.8%
3/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
6.2%
3/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
General disorders
Fatigue
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
4.3%
5/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
6.9%
4/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.9%
3/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
6.6%
7/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
6.2%
3/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
General disorders
Injection site reaction
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
3.5%
4/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
13.8%
8/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
6.6%
7/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
14.6%
7/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
General disorders
Non-cardiac chest pain
|
5.2%
3/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.6%
3/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
11.8%
6/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
4.7%
5/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
General disorders
Oedema peripheral
|
6.9%
4/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.6%
3/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
7.8%
4/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
4.7%
5/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
10.4%
5/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.9%
3/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
3.8%
4/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
10.4%
5/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Infections and infestations
Influenza
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.6%
3/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.9%
3/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
8.5%
9/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
8.3%
4/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.9%
3/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Infections and infestations
Sinusitis
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.9%
3/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.8%
3/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
4/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
3.5%
4/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.2%
3/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
13.7%
7/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
7.5%
8/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
8.3%
4/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
3.5%
4/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
6.9%
4/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
7.8%
4/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
6.6%
7/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
10.4%
5/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.2%
3/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
8.7%
10/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
8.6%
5/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
9.8%
5/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
15.1%
16/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
18.8%
9/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.2%
6/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
11.8%
6/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
13.2%
14/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
4.2%
2/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.9%
3/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.8%
3/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
9.8%
5/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
4.7%
5/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.94%
1/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
6.2%
3/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
4/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
7.0%
8/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
12.1%
7/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
15.7%
8/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
6.6%
7/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
6.2%
3/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
4.3%
5/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
3.4%
2/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
7.8%
4/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
9.4%
10/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
14.6%
7/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
7.8%
9/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.2%
3/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
7.8%
4/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
3.8%
4/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.6%
3/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.7%
6/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
4.2%
2/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.2%
3/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
6.1%
7/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.2%
3/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
13.7%
7/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.7%
6/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
2/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.9%
3/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.4%
2/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
15.7%
8/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
6.6%
7/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
6.2%
3/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
2/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
3.5%
4/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.2%
3/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
3.9%
2/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.8%
3/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Nervous system disorders
Dizziness
|
6.9%
4/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
6.9%
4/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
7.8%
4/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
4.7%
5/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
8.3%
4/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Nervous system disorders
Headache
|
6.9%
4/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
8.7%
10/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
8.6%
5/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.9%
3/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.7%
6/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
8.3%
4/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Psychiatric disorders
Depression
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
2/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
6.6%
7/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.6%
3/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
17.6%
9/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
8.5%
9/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
1.7%
1/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.9%
3/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
5.2%
3/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.8%
3/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
2.1%
1/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
|
Vascular disorders
Hypertension
|
3.4%
2/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
0.87%
1/115 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
3.4%
2/58 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
3.9%
2/51 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
7.5%
8/106 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
4.2%
2/48 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER