Trial Outcomes & Findings for Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE) (NCT NCT02476006)
NCT ID: NCT02476006
Last Updated: 2022-03-28
Results Overview
Adverse Event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Treatment-emergent AEs (TEAEs) were defined as AEs that that developed or worsened or became serious during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
998 participants
Primary outcome timeframe
From first injection of investigational medicinal product (IMP) up to 2 weeks after last dose of study drug (Week 120)
Results posted on
2022-03-28
Participant Flow
The study was conducted at 156 sites in 17 countries. A total of 1305 participants were screened between 23-June-2015 to 27-December 2016, of whom 307 were screen failures. Screen failures were mainly due to exclusion criteria met.
A total of 998 participants were enrolled in the study.
Participant milestones
| Measure |
Alirocumab
Participants received Alirocumab 150 milligram (mg) subcutaneously (SC) once every two weeks (Q2W) or 75 mg SC Q2W added to stable lipid modifying therapies (LMT) up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
|
|---|---|
|
Overall Study
STARTED
|
998
|
|
Overall Study
Treated
|
994
|
|
Overall Study
COMPLETED
|
878
|
|
Overall Study
NOT COMPLETED
|
120
|
Reasons for withdrawal
| Measure |
Alirocumab
Participants received Alirocumab 150 milligram (mg) subcutaneously (SC) once every two weeks (Q2W) or 75 mg SC Q2W added to stable lipid modifying therapies (LMT) up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
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|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Lack of treatment efficacy
|
2
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Participant did not wish to continue
|
39
|
|
Overall Study
Adverse Event
|
41
|
|
Overall Study
Poor compliance to study protocol
|
3
|
|
Overall Study
Sponsor decision
|
6
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Study ended treatment not available
|
4
|
|
Overall Study
Switched to commercial drug
|
4
|
|
Overall Study
Excluded from study
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Enrolled but not treated
|
4
|
Baseline Characteristics
Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)
Baseline characteristics by cohort
| Measure |
Alirocumab
n=994 Participants
Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
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|---|---|
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Age, Continuous
|
56.6 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
369 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
625 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
969 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Oriental
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first injection of investigational medicinal product (IMP) up to 2 weeks after last dose of study drug (Week 120)Population: Analysis was performed on safety population.
Adverse Event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Treatment-emergent AEs (TEAEs) were defined as AEs that that developed or worsened or became serious during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
Outcome measures
| Measure |
Alirocumab
n=994 Participants
Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
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|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE
|
71.6 percentage of participants
|
|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Any treatment emergent SAE
|
16.2 percentage of participants
|
|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to death
|
0.2 percentage of participants
|
|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to treatment discontinuation
|
4.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on modified intent-to-treat population (mITT): all enrolled participants who received at least one dose or part of a dose of alirocumab and had an evaluable efficacy endpoint during the efficacy treatment period (defined as time period from the first injection of alirocumab up to the day of last injection +21 days).
Calculated LDL-C values were obtained using the Friedewald formula. Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - \[Triglyceride/5\]). Baseline value was defined as the last observation before the first dose of the treatment.
Outcome measures
| Measure |
Alirocumab
n=921 Participants
Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
|
|---|---|
|
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
|
-54.84 percent change
Standard Deviation 20.06
|
SECONDARY outcome
Timeframe: At Week 12Population: Analysis was performed on mITT population.
LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C \<100 mg/dL (2.59 mmol/L) at week 12 were reported.
Outcome measures
| Measure |
Alirocumab
n=921 Participants
Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
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|---|---|
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Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12
|
74.6 percentage of participants
Interval 71.7 to 77.4
|
SECONDARY outcome
Timeframe: At Week 12Population: Analysis was performed on mITT population.
LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C \<70 mg/dL (1.81 mmol/L) at week 12 were reported.
Outcome measures
| Measure |
Alirocumab
n=921 Participants
Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
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|---|---|
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Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 12
|
50.2 percentage of participants
Interval 46.9 to 53.4
|
SECONDARY outcome
Timeframe: At Week 12Population: Analysis was performed on mITT population.
LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached LDL-C \<70 mg/dL at Week 12 and/or \>=50% reduction from baseline in LDL-C at Week 12 are reported.
Outcome measures
| Measure |
Alirocumab
n=921 Participants
Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
|
|---|---|
|
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) and/or >=50% Reduction From Baseline in LDL-C at Week 12
|
69.1 percentage of participants
Interval 66.0 to 72.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT population.
Baseline value was defined as the last observation before the first dose of the treatment.
Outcome measures
| Measure |
Alirocumab
n=921 Participants
Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
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|---|---|
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Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
|
-45.89 percent change
Standard Deviation 35.82
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT population.
Baseline value was defined as the last observation before the first dose of the treatment.
Outcome measures
| Measure |
Alirocumab
n=921 Participants
Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
|
|---|---|
|
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12
|
-38.28 percent change
Standard Deviation 15.20
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT population.
Baseline value was defined as the last observation before the first dose of the treatment.
Outcome measures
| Measure |
Alirocumab
n=921 Participants
Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
|
|---|---|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12
|
4.37 percent change
Standard Deviation 17.29
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT population.
Baseline value was defined as the last observation before the first dose of the treatment.
Outcome measures
| Measure |
Alirocumab
n=921 Participants
Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
|
|---|---|
|
Percent Change From Baseline in Triglycerides at Week 12
|
-8.28 percent change
Standard Deviation 33.99
|
SECONDARY outcome
Timeframe: Baseline (Pre-SIAQ), Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96Population: Pre and Post-SIAQ population: participants from the safety population who self-injected the training injection \& completed a Pre-SIAQ before first self-injection, who self-injected study drug at least once during the study and completed a Post-SIAQ. Here, number analyzed = participants with available data at specified time points.
Pre-SIAQ: self-completed before first self-injection \& Post-SIAQ: self-completed after self-injection. Pre-SIAQ consisted of 7 items grouped into 3 domains:feelings about injections,self-confidence \& satisfaction with self-injection. Post-SIAQ consisted of 21 items grouped into 6 domains:feelings about injections,self-image,self-confidence,injection-site reactions,ease of use \& satisfaction with self-injection. Participants rated each item on 5-point (or 6-point) semantic Likert-type scale, where lower numbers indicate a worse experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience). Transformed scores for items contributing to a domain were then averaged into a domain score. Each domain score ranges from 0 (worst experience) to 10 (best experience), higher score=better acceptability. Domain scores common to the Pre \& Post SIAQ were analyzed on participants belonging to Pre \& Post-SIAQ population and are reported.
Outcome measures
| Measure |
Alirocumab
n=952 Participants
Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
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|---|---|
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Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Feelings about injections: Baseline
|
8.6 units on a scale
Standard Deviation 1.8
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Feeling about injections: Week 4
|
9.1 units on a scale
Standard Deviation 1.4
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Feeling about injections: Week 8
|
9.1 units on a scale
Standard Deviation 1.4
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Feeling about injections: Week 12
|
9.2 units on a scale
Standard Deviation 1.4
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Feeling about injections: Week 24
|
9.2 units on a scale
Standard Deviation 1.4
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Feeling about injections: Week 48
|
9.2 units on a scale
Standard Deviation 1.4
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Feeling about injections: Week 72
|
9.2 units on a scale
Standard Deviation 1.4
|
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Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Feeling about injections: Week 96
|
9.3 units on a scale
Standard Deviation 1.3
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Self confidence: Baseline
|
6.9 units on a scale
Standard Deviation 2.4
|
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Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Self Confidence: Week 4
|
8.0 units on a scale
Standard Deviation 2.1
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Self Confidence: Week 8
|
8.1 units on a scale
Standard Deviation 2.0
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Self Confidence: Week 12
|
8.1 units on a scale
Standard Deviation 1.9
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Self Confidence: Week 24
|
8.0 units on a scale
Standard Deviation 2.1
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Self Confidence: Week 48
|
8.1 units on a scale
Standard Deviation 2.1
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Self Confidence: Week 72
|
8.3 units on a scale
Standard Deviation 2.0
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Self Confidence: Week 96
|
8.4 units on a scale
Standard Deviation 2.0
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Satisfaction with self injection: Baseline
|
7.2 units on a scale
Standard Deviation 2.5
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Satisfaction with self-injections: Week 4
|
8.5 units on a scale
Standard Deviation 1.6
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Satisfaction with self-injections: Week 8
|
8.7 units on a scale
Standard Deviation 1.6
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Satisfaction with self-injections: Week 12
|
8.7 units on a scale
Standard Deviation 1.6
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Satisfaction with self-injections: Week 24
|
8.6 units on a scale
Standard Deviation 1.8
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Satisfaction with self-injections: Week 48
|
8.7 units on a scale
Standard Deviation 1.5
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Satisfaction with self-injections: Week 72
|
8.8 units on a scale
Standard Deviation 1.7
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Satisfaction with self-injections: Week 96
|
8.8 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96Population: POST-SIAQ population: participants from safety population who self-injected at least once during the study and completed a POST-SIAQ regardless of completion of PRE-SIAQ. Here, number analyzed = participants with available data at specified time points.
SIAQ: contained 2 modules: Pre-SIAQ and Post-SIAQ. Post-SIAQ: self-completed after self-injection. Post-SIAQ consisted of 21 items grouped into 6 domains: feelings about injections, self-image, self-confidence, injection-site reactions, ease of use \& satisfaction with self-injection. Participants rated each item on 5-point (or 6-point) semantic Likert-type scale, where lower numbers indicated a worse experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item. Transformed scores for items contributing to a domain were then averaged into a domain score. Each domain score ranges from 0 (worst experience) to 10 (best experience), higher score=better acceptability. Domain scores which are not in common with Pre-SIAQ were analyzed on the Post-SIAQ population and are reported here.
Outcome measures
| Measure |
Alirocumab
n=979 Participants
Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
|
|---|---|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Self Image: Week 4
|
9.4 units on a scale
Standard Deviation 1.4
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Self Image: Week 8
|
9.4 units on a scale
Standard Deviation 1.4
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Self Image: Week 12
|
9.4 units on a scale
Standard Deviation 1.4
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Self Image: Week 24
|
9.3 units on a scale
Standard Deviation 1.5
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Self Image: Week 48
|
9.4 units on a scale
Standard Deviation 1.4
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Self Image: Week 72
|
9.3 units on a scale
Standard Deviation 1.5
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Self Image: Week 96
|
9.4 units on a scale
Standard Deviation 1.4
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Injection-site reactions: Week 4
|
9.6 units on a scale
Standard Deviation 0.7
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Injection-site reactions: Week 8
|
9.6 units on a scale
Standard Deviation 0.8
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Injection-site reactions: Week 12
|
9.6 units on a scale
Standard Deviation 0.7
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Injection-site reactions: Week 24
|
9.5 units on a scale
Standard Deviation 0.9
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Injection-site reactions: Week 48
|
9.5 units on a scale
Standard Deviation 0.8
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Injection-site reactions: Week 72
|
9.5 units on a scale
Standard Deviation 0.8
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Injection-site reactions: Week 96
|
9.5 units on a scale
Standard Deviation 0.8
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Ease of use: Week 4
|
8.7 units on a scale
Standard Deviation 1.5
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Ease of use: Week 8
|
8.7 units on a scale
Standard Deviation 1.6
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Ease of use: Week 12
|
8.8 units on a scale
Standard Deviation 1.6
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Ease of use: Week 24
|
8.8 units on a scale
Standard Deviation 1.6
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Ease of use: Week 48
|
8.9 units on a scale
Standard Deviation 1.4
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Ease of use: Week 72
|
9.0 units on a scale
Standard Deviation 1.5
|
|
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Ease of use: Week 96
|
9.0 units on a scale
Standard Deviation 1.4
|
Adverse Events
Alirocumab
Serious events: 161 serious events
Other events: 221 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Alirocumab
n=994 participants at risk
Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.50%
5/994 • Number of events 5 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.50%
5/994 • Number of events 5 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Angina Pectoris
|
1.5%
15/994 • Number of events 15 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Angina Unstable
|
1.2%
12/994 • Number of events 14 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.50%
5/994 • Number of events 5 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Atrial Flutter
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Atrial Tachycardia
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Cardiac Failure
|
0.30%
3/994 • Number of events 3 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.60%
6/994 • Number of events 6 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.60%
6/994 • Number of events 7 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Coronary Ostial Stenosis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Mitral Valve Stenosis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Myocardial Infarction
|
0.30%
3/994 • Number of events 3 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.50%
5/994 • Number of events 5 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Subendocardial Ischaemia
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Congenital, familial and genetic disorders
Accessory Navicular Syndrome
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Eye disorders
Cataract
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Melaena
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Perianal Erythema
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
General disorders
Chest Discomfort
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
General disorders
Chest Pain
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
General disorders
Vascular Stent Stenosis
|
0.40%
4/994 • Number of events 4 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Chronic Hepatitis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Hepatocellular Injury
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Infections and infestations
Bronchitis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Infections and infestations
Campylobacter Colitis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Infections and infestations
Diabetic Foot Infection
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Infections and infestations
Diverticulitis
|
0.30%
3/994 • Number of events 3 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Infections and infestations
Escherichia Sepsis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Infections and infestations
Liver Abscess
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Infections and infestations
Pneumonia
|
0.30%
3/994 • Number of events 3 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Infections and infestations
Urinary Tract Infection
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Infections and infestations
Urosepsis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Infections and infestations
Viral Infection
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Infections and infestations
Wound Infection
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Injury
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.20%
2/994 • Number of events 3 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Peripheral Artery Restenosis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Scapula Fracture
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Spinal Column Injury
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.30%
3/994 • Number of events 3 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Vascular Graft Occlusion
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Investigations
Transaminases Increased
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.30%
3/994 • Number of events 3 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.30%
3/994 • Number of events 3 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia Rheumatica
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm Of Prostate
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer Stage 0, With Cancer In Situ
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear Cell Renal Cell Carcinoma
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Tract Adenoma
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.30%
3/994 • Number of events 3 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Adenocarcinoma
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Cancer
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Amnesia
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Ataxia
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.30%
3/994 • Number of events 3 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Facial Paralysis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Paraesthesia
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Seizure
|
0.10%
1/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Syncope
|
0.30%
3/994 • Number of events 3 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Product Issues
Device Dislocation
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Psychiatric disorders
Completed Suicide
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Psychiatric disorders
Depression
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Psychiatric disorders
Schizophrenia
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Bladder Trabeculation
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Renal Impairment
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Parapsoriasis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Social circumstances
Pregnancy Of Partner
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Vascular disorders
Aortic Aneurysm
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Vascular disorders
Aortic Dissection
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Vascular disorders
Hypertension
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Vascular disorders
Intermittent Claudication
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Vascular disorders
Peripheral Artery Aneurysm
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Vascular disorders
Peripheral Artery Stenosis
|
0.20%
2/994 • Number of events 2 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Vascular disorders
Peripheral Artery Thrombosis
|
0.10%
1/994 • Number of events 1 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
Other adverse events
| Measure |
Alirocumab
n=994 participants at risk
Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
|
|---|---|
|
Infections and infestations
Influenza
|
5.3%
53/994 • Number of events 61 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
78/994 • Number of events 86 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
71/994 • Number of events 93 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
6.1%
61/994 • Number of events 94 • All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER