Trial Outcomes & Findings for Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo (NCT NCT02957682)
NCT ID: NCT02957682
Last Updated: 2021-05-07
Results Overview
CANTAB SWM task assessed cognitive domain of executive function. Colored boxes were shown on a screen. A token was hidden in one of the boxes (never same box twice). Instructions were to touch boxes to search for token until number of tokens found equaled number of boxes. SWM strategy index represents number of times a search began with a different box. Z-score represents standardized measure of how far an individual deviated from study cohort average at baseline. A higher Z-score reflects better performance.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2176 participants
Primary outcome timeframe
Week 96
Results posted on
2021-05-07
Participant Flow
A total of 2176 participants were randomized across 169 sites in Bulgaria, Chile, Estonia, Japan, Mexico, Russian Federation, South Africa, Ukraine, and the United States
Participants who met the eligibility criteria were randomized in 1:1 ratio into 2 treatment groups: placebo and alirocumab. Randomization was stratified by age (less than \[\<\] 65 or greater than or equal to \[\>=\] 65) and by statin use (no statin, low lipophilicity of the concomitant statin, or high lipophilicity of the concomitant statin).
Participant milestones
| Measure |
Placebo
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
1088
|
1088
|
|
Overall Study
Randomized and Treated
|
1085
|
1086
|
|
Overall Study
COMPLETED
|
890
|
919
|
|
Overall Study
NOT COMPLETED
|
198
|
169
|
Reasons for withdrawal
| Measure |
Placebo
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
64
|
67
|
|
Overall Study
Poor Compliance to Protocol
|
30
|
26
|
|
Overall Study
Physician Decision
|
4
|
4
|
|
Overall Study
Study Terminated by Sponsor
|
4
|
3
|
|
Overall Study
Subject Moved
|
10
|
16
|
|
Overall Study
Withdrawal by Subject
|
64
|
33
|
|
Overall Study
Related to IMP Administration
|
3
|
6
|
|
Overall Study
Non-disclosed
|
16
|
12
|
|
Overall Study
Discontinued After Randomization and Prior to Any Treatment
|
3
|
2
|
Baseline Characteristics
Primary safety population included participants from the safety population who had an assessment of the SWM strategy score at baseline (the last score obtained before the first dose of study treatment) and at least 1 score measured during the Treatment-Emergent Adverse Event (TEAE) period.
Baseline characteristics by cohort
| Measure |
Placebo
n=1084 Participants
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1087 Participants
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
Total
n=2171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 Years
STANDARD_DEVIATION 9.02 • n=1084 Participants
|
62.6 Years
STANDARD_DEVIATION 8.88 • n=1087 Participants
|
62.6 Years
STANDARD_DEVIATION 8.95 • n=2171 Participants
|
|
Sex: Female, Male
Female
|
459 Participants
n=1084 Participants
|
448 Participants
n=1087 Participants
|
907 Participants
n=2171 Participants
|
|
Sex: Female, Male
Male
|
625 Participants
n=1084 Participants
|
639 Participants
n=1087 Participants
|
1264 Participants
n=2171 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
137 Participants
n=1084 Participants
|
142 Participants
n=1087 Participants
|
279 Participants
n=2171 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
945 Participants
n=1084 Participants
|
943 Participants
n=1087 Participants
|
1888 Participants
n=2171 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=1084 Participants
|
2 Participants
n=1087 Participants
|
4 Participants
n=2171 Participants
|
|
Race/Ethnicity, Customized
White
|
888 Participants
n=1084 Participants
|
886 Participants
n=1087 Participants
|
1774 Participants
n=2171 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
86 Participants
n=1084 Participants
|
77 Participants
n=1087 Participants
|
163 Participants
n=2171 Participants
|
|
Race/Ethnicity, Customized
Asian
|
19 Participants
n=1084 Participants
|
28 Participants
n=1087 Participants
|
47 Participants
n=2171 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
11 Participants
n=1084 Participants
|
16 Participants
n=1087 Participants
|
27 Participants
n=2171 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1084 Participants
|
0 Participants
n=1087 Participants
|
0 Participants
n=2171 Participants
|
|
Race/Ethnicity, Customized
Other
|
80 Participants
n=1084 Participants
|
80 Participants
n=1087 Participants
|
160 Participants
n=2171 Participants
|
|
CANTAB Cognitive Domain Spatial Working Memory (SWM) Strategy Raw Score
|
15.9 Units on a Scale
STANDARD_DEVIATION 5.03 • n=1035 Participants • Primary safety population included participants from the safety population who had an assessment of the SWM strategy score at baseline (the last score obtained before the first dose of study treatment) and at least 1 score measured during the Treatment-Emergent Adverse Event (TEAE) period.
|
16.05 Units on a Scale
STANDARD_DEVIATION 5.11 • n=1051 Participants • Primary safety population included participants from the safety population who had an assessment of the SWM strategy score at baseline (the last score obtained before the first dose of study treatment) and at least 1 score measured during the Treatment-Emergent Adverse Event (TEAE) period.
|
16.0 Units on a Scale
STANDARD_DEVIATION 5.07 • n=2086 Participants • Primary safety population included participants from the safety population who had an assessment of the SWM strategy score at baseline (the last score obtained before the first dose of study treatment) and at least 1 score measured during the Treatment-Emergent Adverse Event (TEAE) period.
|
PRIMARY outcome
Timeframe: Week 96Population: Primary safety population included participants from the safety population who had an assessment of the SWM strategy score at baseline, and at least 1 score measured during the treatment-emergent adverse event (TEAE) period. The TEAE period is defined as the first double-blind treatment dose to last dose of double-blind treatment + 70 days (10 weeks). Participants were analyzed according to the treatment actually received.
CANTAB SWM task assessed cognitive domain of executive function. Colored boxes were shown on a screen. A token was hidden in one of the boxes (never same box twice). Instructions were to touch boxes to search for token until number of tokens found equaled number of boxes. SWM strategy index represents number of times a search began with a different box. Z-score represents standardized measure of how far an individual deviated from study cohort average at baseline. A higher Z-score reflects better performance.
Outcome measures
| Measure |
Placebo
n=1035 Participants
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1051 Participants
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Cognitive Domain Spatial Working Memory (SWM) Strategy Z-Score at Week 96
|
-0.180 Z-score
Standard Error 0.027
|
-0.200 Z-score
Standard Error 0.027
|
SECONDARY outcome
Timeframe: Week 96Population: Primary safety population included participants from the safety population who had an assessment of the SWM strategy score at baseline, and at least 1 score measured during the treatment-emergent adverse event (TEAE) period. The TEAE period is defined as the first double-blind treatment dose to last dose of double-blind treatment + 70 days (10 weeks). Participants were analyzed according to the treatment actually received.
CANTAB SWM task assessed cognitive domain of executive function. Colored boxes were shown on a screen. A token was hidden in one of the boxes (never same box twice). Instructions were to touch boxes to search for token until number of tokens found equaled number of boxes. SWM strategy index represents number of times a search began with a different box. Lower change from baseline raw scores reflect better SWM performance (i.e. less impairment).
Outcome measures
| Measure |
Placebo
n=1035 Participants
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1051 Participants
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Change From Baseline in CANTAB Cognitive Domain SWM Strategy Raw Score at Week 96
|
-0.9 Units on a Scale
Standard Deviation 4.49
|
-1.0 Units on a Scale
Standard Deviation 4.31
|
SECONDARY outcome
Timeframe: Week 12, 24, 48, 72, and 96Population: Intent-to-treat (ITT) population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized).
Percent change from baseline in calculated LDL-C at Week 12, 24, 48, 72, and 96 was reported. LDL-C was measured using conventional units milligram per deciliter (mg/dL).
Outcome measures
| Measure |
Placebo
n=1051 Participants
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1058 Participants
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 12
|
0.6 Percent Change
Standard Error 1.0
|
-49.6 Percent Change
Standard Error 0.9
|
|
Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 24
|
3.0 Percent Change
Standard Error 1.0
|
-54.2 Percent Change
Standard Error 1.0
|
|
Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 48
|
2.8 Percent Change
Standard Error 1.1
|
-51.4 Percent Change
Standard Error 1.1
|
|
Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 72
|
2.4 Percent Change
Standard Error 1.2
|
-50.4 Percent Change
Standard Error 1.2
|
|
Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 96
|
4.0 Percent Change
Standard Error 1.3
|
-46.2 Percent Change
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Week 12, 24, 48, 72, and 96Population: ITT population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized).
Percent change from baseline in Apo B at Week 12, 24, 48, 72, and 96 was reported. Apo B was measured using conventional units mg/dL.
Outcome measures
| Measure |
Placebo
n=1051 Participants
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1058 Participants
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 12, 24, 48, 72, and 96
Percent change at Week 12
|
0.8 Percent Change
Standard Error 0.7
|
-36.7 Percent Change
Standard Error 0.7
|
|
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 12, 24, 48, 72, and 96
Percent change at Week 24
|
2.1 Percent Change
Standard Error 0.8
|
-40.9 Percent Change
Standard Error 0.8
|
|
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 12, 24, 48, 72, and 96
Percent change at Week 48
|
1.1 Percent Change
Standard Error 0.8
|
-39.0 Percent Change
Standard Error 0.8
|
|
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 12, 24, 48, 72, and 96
Percent change at Week 72
|
0.2 Percent Change
Standard Error 0.9
|
-39.1 Percent Change
Standard Error 0.8
|
|
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 12, 24, 48, 72, and 96
Percent change at Week 96
|
1.4 Percent Change
Standard Error 0.9
|
-36.4 Percent Change
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Week 12, 24, 48, 72, and 96Population: ITT population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized).
Percent change from baseline in non-HDL-C at Week 12, 24, 48, 72, and 96 was reported. Non-HDL-C was measured using conventional units mg/dL.
Outcome measures
| Measure |
Placebo
n=1051 Participants
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1058 Participants
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 12
|
0.7 Percent Change
Standard Error 0.8
|
-40.4 Percent Change
Standard Error 0.8
|
|
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 24
|
2.2 Percent Change
Standard Error 0.9
|
-44.0 Percent Change
Standard Error 0.9
|
|
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 48
|
1.7 Percent Change
Standard Error 0.9
|
-41.1 Percent Change
Standard Error 0.9
|
|
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 72
|
1.7 Percent Change
Standard Error 1.0
|
-40.6 Percent Change
Standard Error 1.0
|
|
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 96
|
2.5 Percent Change
Standard Error 1.1
|
-37.0 Percent Change
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Week 12, 24, 48, 72, and 96Population: ITT population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized).
Percent change from baseline in calculated Total-C at Week 12, 24, 48, 72, and 96 was reported. Total-C was measured using conventional units mg/dL.
Outcome measures
| Measure |
Placebo
n=1051 Participants
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1058 Participants
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 12
|
-0.3 Percent Change
Standard Error 0.6
|
-29.6 Percent Change
Standard Error 0.6
|
|
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 24
|
1.5 Percent Change
Standard Error 0.6
|
-31.8 Percent Change
Standard Error 0.6
|
|
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 48
|
1.1 Percent Change
Standard Error 0.7
|
-29.6 Percent Change
Standard Error 0.7
|
|
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 72
|
1.1 Percent Change
Standard Error 0.7
|
-29.0 Percent Change
Standard Error 0.7
|
|
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 96
|
1.8 Percent Change
Standard Error 0.7
|
-26.5 Percent Change
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Week 12, 24, 48, 72, and 96Population: ITT Population was used. The two-step multiple imputation procedure is used to address missing values in the randomized population. In the first step, the monotone missing pattern is induced in the multiply-imputed data. In the second step, the missing data at subsequent visits are imputed using the regression method for continuous variables.
Percent change from baseline in Lp(a) at Week 12, 24, 48, 72, and 96 was reported. Lp(a) was measured using conventional units mg/dL.
Outcome measures
| Measure |
Placebo
n=1051 Participants
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1058 Participants
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12, 24, 48, 72, and 96
Percent change at Week 12
|
-3.3 Percent Change
Standard Error 0.8
|
-22.4 Percent Change
Standard Error 0.8
|
|
Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12, 24, 48, 72, and 96
Percent change at Week 24
|
-0.5 Percent Change
Standard Error 0.9
|
-24.7 Percent Change
Standard Error 0.9
|
|
Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12, 24, 48, 72, and 96
Percent change at Week 48
|
-1.4 Percent Change
Standard Error 1.0
|
-24.3 Percent Change
Standard Error 1.0
|
|
Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12, 24, 48, 72, and 96
Percent change at Week 72
|
-1.7 Percent Change
Standard Error 1.0
|
-25.1 Percent Change
Standard Error 1.0
|
|
Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12, 24, 48, 72, and 96
Percent change at Week 96
|
4.8 Percent Change
Standard Error 1.1
|
-17.7 Percent Change
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Week 12, 24, 48, 72, and 96Population: ITT population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized).
Percent change from baseline in HDL-C at Week 12, 24, 48, 72, and 96 was reported. HDL-C was measured using conventional units mg/dL.
Outcome measures
| Measure |
Placebo
n=1051 Participants
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1058 Participants
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 96
|
5.5 Percent Change
Standard Error 0.7
|
10.8 Percent Change
Standard Error 0.7
|
|
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 12
|
0.6 Percent Change
Standard Error 0.5
|
5.9 Percent Change
Standard Error 0.5
|
|
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 24
|
3.8 Percent Change
Standard Error 0.6
|
9.0 Percent Change
Standard Error 0.6
|
|
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 48
|
3.8 Percent Change
Standard Error 0.6
|
9.2 Percent Change
Standard Error 0.6
|
|
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24, 48, 72, and 96
Percent change at Week 72
|
4.4 Percent Change
Standard Error 0.7
|
10.3 Percent Change
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Week 12, 24, 48, 72, and 96Population: ITT population was used. The two-step multiple imputation procedure is used to address missing values in the randomized population. In the first step, the monotone missing pattern is induced in the multiply-imputed data. In the second step, the missing data at subsequent visits are imputed using the regression method for continuous variables
Percent change from baseline in TG at Week 12, 24, 48, 72, and 96 was reported. TG was measured using conventional units mg/dL.
Outcome measures
| Measure |
Placebo
n=1051 Participants
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1058 Participants
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Triglycerides (TG) at Week 12, 24, 48, 72, and 96
Percent change at Week 12
|
0.7 Percent Change
Standard Error 1.0
|
-11.0 Percent Change
Standard Error 1.0
|
|
Percent Change From Baseline in Triglycerides (TG) at Week 12, 24, 48, 72, and 96
Percent change at Week 24
|
-1.8 Percent Change
Standard Error 1.0
|
-12.9 Percent Change
Standard Error 1.0
|
|
Percent Change From Baseline in Triglycerides (TG) at Week 12, 24, 48, 72, and 96
Percent change at Week 48
|
-1.8 Percent Change
Standard Error 1.1
|
-11.3 Percent Change
Standard Error 1.1
|
|
Percent Change From Baseline in Triglycerides (TG) at Week 12, 24, 48, 72, and 96
Percent change at Week 72
|
-2.1 Percent Change
Standard Error 1.1
|
-12.3 Percent Change
Standard Error 1.1
|
|
Percent Change From Baseline in Triglycerides (TG) at Week 12, 24, 48, 72, and 96
Percent change at Week 96
|
-2.7 Percent Change
Standard Error 1.1
|
-11.9 Percent Change
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Week 12, 24, 48, 72, and 96Population: ITT population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized).
Percent change from baseline in Apo A-1 at Week 12, 24, 48, 72, and 96 was reported. Apo A-1 was measured using conventional units mg/dL.
Outcome measures
| Measure |
Placebo
n=1051 Participants
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1058 Participants
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein (Apo) A-1 at Week 12, 24, 48, 72, and 96
Percent change at Week 12
|
-1.3 Percent Change
Standard Error 0.4
|
1.7 Percent Change
Standard Error 0.4
|
|
Percent Change From Baseline in Apolipoprotein (Apo) A-1 at Week 12, 24, 48, 72, and 96
Percent change at Week 24
|
2.9 Percent Change
Standard Error 0.4
|
6.1 Percent Change
Standard Error 0.4
|
|
Percent Change From Baseline in Apolipoprotein (Apo) A-1 at Week 12, 24, 48, 72, and 96
Percent change at Week 48
|
4.7 Percent Change
Standard Error 0.4
|
7.7 Percent Change
Standard Error 0.4
|
|
Percent Change From Baseline in Apolipoprotein (Apo) A-1 at Week 12, 24, 48, 72, and 96
Percent change at Week 72
|
4.4 Percent Change
Standard Error 0.4
|
7.8 Percent Change
Standard Error 0.4
|
|
Percent Change From Baseline in Apolipoprotein (Apo) A-1 at Week 12, 24, 48, 72, and 96
Percent change at Week 96
|
4.2 Percent Change
Standard Error 0.4
|
7.5 Percent Change
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Week 12, 24, 48, 72, and 96Population: ITT population was used. The two-step multiple imputation procedure is used to address missing values in the randomized population. In the first step, the monotone missing pattern is induced in the multiply-imputed data. In the second step, the missing data at subsequent visits are imputed using the regression method for continuous variables.
Percentage of participants who reached LDL-C level \< 70 mg/dL (1.81 mmol/L) at Week 12, 24, 48, 72, and 96 were reported.
Outcome measures
| Measure |
Placebo
n=1051 Participants
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1058 Participants
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 70 mg/dL (1.81 Millimoles Per Liter [mmol/L]) at Week 12, 24, 48, 72, and 96
Week 12
|
10.3 Percentage of Participants
|
69.4 Percentage of Participants
|
|
Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 70 mg/dL (1.81 Millimoles Per Liter [mmol/L]) at Week 12, 24, 48, 72, and 96
Week 24
|
8.4 Percentage of Participants
|
74.7 Percentage of Participants
|
|
Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 70 mg/dL (1.81 Millimoles Per Liter [mmol/L]) at Week 12, 24, 48, 72, and 96
Week 48
|
10.7 Percentage of Participants
|
71.4 Percentage of Participants
|
|
Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 70 mg/dL (1.81 Millimoles Per Liter [mmol/L]) at Week 12, 24, 48, 72, and 96
Week 72
|
11.3 Percentage of Participants
|
69.7 Percentage of Participants
|
|
Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 70 mg/dL (1.81 Millimoles Per Liter [mmol/L]) at Week 12, 24, 48, 72, and 96
Week 96
|
10.7 Percentage of Participants
|
64.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12, 24, 48, 72, and 96Population: ITT population was used. The two-step multiple imputation procedure is used to address missing values in the randomized population. In the first step, the monotone missing pattern is induced in the multiply-imputed data. In the second step, the missing data at subsequent visits are imputed using the regression method for continuous variables.
Percentage of participants who reached LDL-C level \< 50 mg/dL (1.29 mmol/L) at Week 12, 24, 48, 72, and 96 were reported.
Outcome measures
| Measure |
Placebo
n=1051 Participants
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1058 Participants
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 50 mg/dL (1.29 mmol/L) at Week 12, 24, 48, 72, and 96
Week 72
|
2.5 Percentage of Participants
|
52.1 Percentage of Participants
|
|
Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 50 mg/dL (1.29 mmol/L) at Week 12, 24, 48, 72, and 96
Week 12
|
1.7 Percentage of Participants
|
45.6 Percentage of Participants
|
|
Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 50 mg/dL (1.29 mmol/L) at Week 12, 24, 48, 72, and 96
Week 24
|
2.0 Percentage of Participants
|
56.9 Percentage of Participants
|
|
Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 50 mg/dL (1.29 mmol/L) at Week 12, 24, 48, 72, and 96
Week 48
|
2.1 Percentage of Participants
|
51.3 Percentage of Participants
|
|
Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 50 mg/dL (1.29 mmol/L) at Week 12, 24, 48, 72, and 96
Week 96
|
2.4 Percentage of Participants
|
46.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Week 96Population: Safety population included all participants randomized and exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
An Adverse Event (AE) was any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. TEAE was defined as AEs that developed or worsened/became serious during on-treatment period (time from the first double-blind study treatment injection up to 70 days after the last double-blind study treatment injection). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-participant hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Outcome measures
| Measure |
Placebo
n=1084 Participants
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1087 Participants
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with any TEAE leading to permanent treatment discontinuation
|
59 Participants
|
64 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with any TEAEs
|
857 Participants
|
866 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with any Serious TEAEs
|
216 Participants
|
189 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with any TEAE leading to death
|
17 Participants
|
13 Participants
|
Adverse Events
Placebo
Serious events: 216 serious events
Other events: 387 other events
Deaths: 24 deaths
Alirocumab 75 Q2W/Up150 Q2W
Serious events: 189 serious events
Other events: 366 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Placebo
n=1084 participants at risk
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1087 participants at risk
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Angina unstable
|
1.5%
16/1084 • Number of events 17 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
1.3%
14/1087 • Number of events 17 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
13/1084 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.46%
5/1087 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Angina pectoris
|
0.92%
10/1084 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
1.0%
11/1087 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Coronary artery disease
|
0.74%
8/1084 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.55%
6/1087 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.65%
7/1084 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.46%
5/1087 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.37%
4/1084 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Cardiac failure
|
0.37%
4/1084 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.37%
4/1087 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Myocardial infarction
|
0.37%
4/1084 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Cardiac failure acute
|
0.28%
3/1084 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.28%
3/1084 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.37%
4/1087 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Acute left ventricular failure
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Atrioventricular block complete
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Cardiac arrest
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.28%
3/1087 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Ventricular tachycardia
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Arrhythmia
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Cardiac failure chronic
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Coronary artery occlusion
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Frederick's syndrome
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Hypertension
|
0.65%
7/1084 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.55%
6/1087 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Aortic aneurysm
|
0.28%
3/1084 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Hypertensive crisis
|
0.28%
3/1084 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.28%
3/1087 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.28%
3/1084 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.37%
4/1087 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Deep vein thrombosis
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Peripheral ischaemia
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Peripheral vascular disorder
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Dry gangrene
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Hypertensive urgency
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Hypotension
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Lymphoedema
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Orthostatic hypotension
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Paget-Schroetter syndrome
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Peripheral artery occlusion
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Peripheral artery stenosis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Varicose vein
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Venous thrombosis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Venous thrombosis limb
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Pneumonia
|
0.46%
5/1084 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.37%
4/1087 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Sepsis
|
0.37%
4/1084 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Cellulitis
|
0.28%
3/1084 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.37%
4/1087 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Gastroenteritis
|
0.28%
3/1084 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Appendicitis
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Cystitis
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Bronchiolitis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Bronchitis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Dengue haemorrhagic fever
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Dysentery
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Endocarditis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Influenza
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Pyelonephritis acute
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Urinary tract infection
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.28%
3/1087 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Urosepsis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Haemorrhagic fever with renal syndrome
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.28%
3/1084 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acinic cell carcinoma of salivary gland
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of epididymis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage II
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.28%
3/1087 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer metastatic
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Ischaemic stroke
|
0.46%
5/1084 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.37%
4/1087 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Carotid artery stenosis
|
0.37%
4/1084 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.28%
3/1084 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.28%
3/1084 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.28%
3/1087 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Sciatica
|
0.18%
2/1084 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Cerebral infarction
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Diabetic neuropathy
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Lacunar stroke
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Migraine
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Seizure
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Syncope
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.28%
3/1087 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Thalamic infarction
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Vascular encephalopathy
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Multifocal motor neuropathy
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Vertigo CNS origin
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.37%
4/1084 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.37%
4/1084 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.37%
4/1084 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.28%
3/1087 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.28%
3/1084 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.09%
1/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Colitis
|
0.09%
1/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Cyclic vomiting syndrome
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation haemorrhagic
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Nausea
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Oroantral fistula
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Coronary bypass thrombosis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Strangulated incisional hernia
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Coronary bypass stenosis
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
General disorders
Non-cardiac chest pain
|
0.28%
3/1084 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
General disorders
Chest pain
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
General disorders
Death
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
General disorders
Fatigue
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
General disorders
Medical device site haematoma
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
General disorders
Oedema peripheral
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
General disorders
Sudden cardiac death
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
General disorders
Vascular stent occlusion
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
General disorders
Chest discomfort
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
General disorders
Stent-graft endoleak
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
General disorders
Sudden death
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.37%
4/1084 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.28%
3/1084 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Renal and urinary disorders
Bladder tamponade
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Renal and urinary disorders
Renal impairment
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Renal and urinary disorders
Urethral stenosis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Renal and urinary disorders
Urinary retention
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.55%
6/1087 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Back disorder
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.09%
1/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Hepatobiliary disorders
Biliary colic
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.18%
2/1084 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.18%
2/1087 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.28%
3/1084 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.18%
2/1084 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Reproductive system and breast disorders
Cervix haemorrhage uterine
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Blood and lymphatic system disorders
Splenic haematoma
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Blood and lymphatic system disorders
Monoclonal B-cell lymphocytosis
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Eye disorders
Amaurosis fugax
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Eye disorders
Retinal detachment
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Eye disorders
Cataract
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.37%
4/1087 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Eye disorders
Glaucoma
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Surgical and medical procedures
Hospitalisation
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Endocrine disorders
Hyperthyroidism
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Psychiatric disorders
Somatic symptom disorder
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.09%
1/1084 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.00%
0/1087 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Skin and subcutaneous tissue disorders
Ischaemic skin ulcer
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Congenital, familial and genetic disorders
Vestibulocerebellar syndrome
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Social circumstances
Homicide
|
0.00%
0/1084 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
0.09%
1/1087 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
Other adverse events
| Measure |
Placebo
n=1084 participants at risk
Participants received subcutaneous (SC) injections of placebo matched to alirocumab every 2 weeks (Q2W) up to 94 weeks.
|
Alirocumab 75 Q2W/Up150 Q2W
n=1087 participants at risk
Participants received SC injections of alirocumab at a dose of 75 milligrams (mg) Q2W and up-titrated to 150 mg Q2W at Week 12 in a blinded fashion (if LDL-C ≥ 50 mg/dL at Week 8) up to 94 weeks.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
6.0%
65/1084 • Number of events 72 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
5.5%
60/1087 • Number of events 78 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Influenza
|
6.4%
69/1084 • Number of events 77 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
5.8%
63/1087 • Number of events 69 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Nasopharyngitis
|
8.2%
89/1084 • Number of events 117 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
7.5%
82/1087 • Number of events 98 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Infections and infestations
Urinary tract infection
|
4.2%
46/1084 • Number of events 65 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
5.6%
61/1087 • Number of events 78 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
71/1084 • Number of events 82 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
5.5%
60/1087 • Number of events 66 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Nervous system disorders
Headache
|
7.8%
85/1084 • Number of events 123 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
6.5%
71/1087 • Number of events 83 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
|
Vascular disorders
Hypertension
|
6.7%
73/1084 • Number of events 93 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
5.9%
64/1087 • Number of events 81 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).
Safety population included all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. Participants were analyzed according to the treatment received (placebo or Praluent 75 mg Q2W/up-titrate 150 mg Q2W).
|
Additional Information
Clinical Trial Management
Regeneron Pharmaceuticals, Inc
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER