Trial Outcomes & Findings for Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension (NCT NCT02867813)
NCT ID: NCT02867813
Last Updated: 2023-04-07
Results Overview
All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.
COMPLETED
PHASE3
5035 participants
Up to 5 years
2023-04-07
Participant Flow
This was an open-label extension of study 20110118 (NCT01764633). Eligible participants were enrolled after the completion of the 20110118 study. 5035 participants were enrolled at 195 centers in Czech Republic, Hungary, Poland, Russia, Slovakia, Ukraine, and the United States from 02 September 2016 to 17 March 2022.
5035 participants were enrolled and 5031 of those participants received study drug.
Participant milestones
| Measure |
Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study
Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg every 2 weeks Q2W or 420 mg monthly QM in the open label extension, according to the participant's preference.
|
Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study
Participants in the parent study who received evolocumab subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participant's preference.
|
|---|---|---|
|
Overall Study
STARTED
|
2535
|
2500
|
|
Overall Study
COMPLETED
|
2084
|
2090
|
|
Overall Study
NOT COMPLETED
|
451
|
410
|
Reasons for withdrawal
| Measure |
Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study
Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg every 2 weeks Q2W or 420 mg monthly QM in the open label extension, according to the participant's preference.
|
Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study
Participants in the parent study who received evolocumab subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participant's preference.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
57
|
56
|
|
Overall Study
Decision by Sponsor
|
7
|
7
|
|
Overall Study
Lost to Follow-up
|
91
|
78
|
|
Overall Study
Missing
|
2
|
1
|
|
Overall Study
Death
|
294
|
268
|
Baseline Characteristics
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
Baseline characteristics by cohort
| Measure |
Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study
n=2532 Participants
Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg every 2 weeks Q2W or 420 mg monthly QM in the open label extension, according to the participant's preference.
|
Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study
n=2499 Participants
Participants in the parent study who received evolocumab subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participant's preference.
|
Total
n=5031 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
62.4 Years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
62.3 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
638 Participants
n=5 Participants
|
622 Participants
n=7 Participants
|
1260 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1894 Participants
n=5 Participants
|
1877 Participants
n=7 Participants
|
3771 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2477 Participants
n=5 Participants
|
2436 Participants
n=7 Participants
|
4913 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
111 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2392 Participants
n=5 Participants
|
2345 Participants
n=7 Participants
|
4737 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: OLE Safety Analysis Set which included all participants who received at least 1 dose of open-label evolocumab in the OLE study.
All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.
Outcome measures
| Measure |
Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study
n=2532 Participants
Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg every 2 weeks Q2W or 420 mg monthly QM in the open label extension, according to the participant's preference.
|
Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study
n=2499 Participants
Participants in the parent study who received evolocumab subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participant's preference.
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event
|
2144 Participants
|
2084 Participants
|
SECONDARY outcome
Timeframe: Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260Population: OLE Safety Analysis Set which included all participants who received at least 1 dose of open-label evolocumab in the OLE study.
Outcome measures
| Measure |
Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study
n=2532 Participants
Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg every 2 weeks Q2W or 420 mg monthly QM in the open label extension, according to the participant's preference.
|
Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study
n=2499 Participants
Participants in the parent study who received evolocumab subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participant's preference.
|
|---|---|---|
|
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Week 12
|
-55.93 Percent Change
Standard Deviation 33.73
|
-58.43 Percent Change
Standard Deviation 30.64
|
|
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Week 24
|
-56.69 Percent Change
Standard Deviation 33.58
|
-58.38 Percent Change
Standard Deviation 31.52
|
|
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Week 48
|
-58.52 Percent Change
Standard Deviation 33.66
|
-59.05 Percent Change
Standard Deviation 33.06
|
|
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Week 72
|
-56.35 Percent Change
Standard Deviation 33.73
|
-56.90 Percent Change
Standard Deviation 33.14
|
|
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Week 96
|
-55.70 Percent Change
Standard Deviation 33.72
|
-56.62 Percent Change
Standard Deviation 33.36
|
|
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Week 120
|
-53.37 Percent Change
Standard Deviation 36.77
|
-54.89 Percent Change
Standard Deviation 35.99
|
|
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Week 144
|
-56.96 Percent Change
Standard Deviation 32.82
|
-57.38 Percent Change
Standard Deviation 32.34
|
|
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Week 168
|
-56.49 Percent Change
Standard Deviation 37.04
|
-58.22 Percent Change
Standard Deviation 34.60
|
|
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Week 192
|
-57.42 Percent Change
Standard Deviation 35.43
|
-58.81 Percent Change
Standard Deviation 33.27
|
|
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Week 216
|
-54.68 Percent Change
Standard Deviation 35.53
|
-57.11 Percent Change
Standard Deviation 32.89
|
|
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Week 260
|
-53.69 Percent Change
Standard Deviation 37.51
|
-56.63 Percent Change
Standard Deviation 36.14
|
SECONDARY outcome
Timeframe: Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260Population: OLE Safety Analysis Set which included all participants who received at least 1 dose of open-label evolocumab in the OLE study.
Outcome measures
| Measure |
Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study
n=2532 Participants
Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg every 2 weeks Q2W or 420 mg monthly QM in the open label extension, according to the participant's preference.
|
Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study
n=2499 Participants
Participants in the parent study who received evolocumab subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participant's preference.
|
|---|---|---|
|
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Week 48
|
61.7 Percentage of Participants
Interval 59.8 to 63.7
|
61.9 Percentage of Participants
Interval 60.0 to 63.9
|
|
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Week 72
|
59.7 Percentage of Participants
Interval 57.7 to 61.7
|
58.5 Percentage of Participants
Interval 56.5 to 60.5
|
|
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Week 12
|
58.7 Percentage of Participants
Interval 56.7 to 60.6
|
61.4 Percentage of Participants
Interval 59.4 to 63.3
|
|
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Week 24
|
60.2 Percentage of Participants
Interval 58.2 to 62.1
|
61.6 Percentage of Participants
Interval 59.7 to 63.5
|
|
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Week 96
|
57.3 Percentage of Participants
Interval 55.3 to 59.3
|
59.9 Percentage of Participants
Interval 57.8 to 61.9
|
|
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Week 120
|
54.6 Percentage of Participants
Interval 52.5 to 56.6
|
56.4 Percentage of Participants
Interval 54.4 to 58.5
|
|
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Week 144
|
59.6 Percentage of Participants
Interval 57.6 to 61.7
|
60.4 Percentage of Participants
Interval 58.3 to 62.4
|
|
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Week 168
|
60.9 Percentage of Participants
Interval 58.8 to 63.0
|
61.5 Percentage of Participants
Interval 59.4 to 63.5
|
|
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Week 192
|
61.8 Percentage of Participants
Interval 59.4 to 64.1
|
62.3 Percentage of Participants
Interval 59.9 to 64.7
|
|
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Week 216
|
56.0 Percentage of Participants
Interval 53.6 to 58.3
|
59.2 Percentage of Participants
Interval 56.9 to 61.5
|
|
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Week 260
|
56.9 Percentage of Participants
Interval 54.6 to 59.1
|
59.2 Percentage of Participants
Interval 56.9 to 61.4
|
Adverse Events
Placebo in Parent Study
Evolocumab in Parent Study
Serious adverse events
| Measure |
Placebo in Parent Study
n=2532 participants at risk
Participants with Placebo in Parent Study
|
Evolocumab in Parent Study
n=2499 participants at risk
Participants with Evolocumab in Parent Study
|
|---|---|---|
|
Infections and infestations
Parotid abscess
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Perihepatic abscess
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.51%
13/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.72%
18/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.32%
8/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Acute cardiac event
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.39%
10/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.24%
6/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.9%
74/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
2.1%
52/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Angina pectoris
|
2.2%
56/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
2.1%
52/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Angina unstable
|
1.9%
49/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
1.5%
37/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Aortic valve disease
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Arrhythmic storm
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
57/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
1.9%
47/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Atrial flutter
|
0.43%
11/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.52%
13/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Atrioventricular block
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.36%
9/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.36%
9/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Bradycardia
|
0.32%
8/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.36%
9/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Bundle branch block left
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Cardiac arrest
|
0.63%
16/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.52%
13/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Cardiac asthma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Cardiac failure
|
1.8%
46/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
1.8%
44/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Cardiac failure acute
|
0.83%
21/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.68%
17/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.51%
13/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.92%
23/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.5%
37/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
1.6%
40/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Cardiogenic shock
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Cardiomyopathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Coronary artery disease
|
1.6%
41/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
1.2%
30/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.32%
8/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Heart valve incompetence
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Left ventricular failure
|
0.32%
8/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Myocardial infarction
|
0.99%
25/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.80%
20/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.59%
15/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.44%
11/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Paroxysmal atrioventricular block
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Pericardial effusion
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Pericarditis
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Right ventricular failure
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Sinus bradycardia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.28%
7/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.32%
8/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.32%
8/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Tachycardia
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.24%
6/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.67%
17/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.56%
14/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Congenital, familial and genetic disorders
Talipes
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Ear and labyrinth disorders
Deafness
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Ear and labyrinth disorders
External ear disorder
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Ear and labyrinth disorders
Neurosensory hypoacusis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Ear and labyrinth disorders
Vertigo labyrinthine
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Ear and labyrinth disorders
Vestibular ataxia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Endocrine disorders
Goitre
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Eye disorders
Amaurosis fugax
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Eye disorders
Cataract
|
0.43%
11/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.32%
8/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Eye disorders
Choroidal detachment
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Eye disorders
Diplopia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Eye disorders
Epiretinal membrane
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Eye disorders
Eyelid bleeding
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Eye disorders
Eyelid ptosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Eye disorders
Glaucoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Eye disorders
Macular rupture
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Eye disorders
Retinal detachment
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Eye disorders
Visual impairment
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Abdominal symptom
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Anal stenosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Colitis
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Colon dysplasia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Femoral hernia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Femoral hernia strangulated
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Food poisoning
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Gastric volvulus
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Gastritis
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Gastritis alcoholic
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.43%
11/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.64%
16/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation haemorrhagic
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.24%
6/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Ileus
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.32%
8/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.44%
11/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Intestinal angina
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.24%
6/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.28%
7/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Nausea
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.40%
10/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Salivary gland cyst
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.24%
6/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.24%
6/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.32%
8/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Gastrointestinal disorders
Vomiting
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Asthenia
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Chest discomfort
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Chest pain
|
0.59%
15/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.28%
7/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Complication associated with device
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Death
|
0.36%
9/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.40%
10/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Exercise tolerance decreased
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Hernia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Impaired healing
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Implant site haematoma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Implant site pain
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Inflammation
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.24%
6/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Non-cardiac chest pain
|
1.0%
26/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
1.5%
37/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Pneumatosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Prosthetic cardiac valve stenosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Pyrexia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Stent-graft endoleak
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Sudden cardiac death
|
0.28%
7/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Sudden death
|
0.39%
10/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.24%
6/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Vascular stent occlusion
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
General disorders
Vascular stent stenosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.28%
7/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.40%
10/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.51%
13/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.44%
11/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Hepatitis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Hyperplastic cholecystopathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Immune system disorders
Anaphylactic reaction
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Abdominal abscess
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Abscess
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Abscess bacterial
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Abscess limb
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Acute endocarditis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Anal abscess
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Appendicitis
|
0.28%
7/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Appendicitis perforated
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Arthritis bacterial
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Arthritis infective
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Atypical pneumonia
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Bacteraemia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Breast abscess
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Bronchitis
|
0.32%
8/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.40%
10/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
COVID-19
|
0.59%
15/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.60%
15/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.3%
32/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.92%
23/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Cellulitis
|
0.67%
17/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.80%
20/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Cholecystitis infective
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Cholera
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Coccidioidomycosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Cystitis
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Cystitis klebsiella
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Device related infection
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Diabetic foot infection
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Diverticulitis
|
0.43%
11/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.28%
7/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Eczema infected
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Erysipelas
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Escherichia sepsis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Fungal skin infection
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Gallbladder abscess
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Gallbladder empyema
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Gangrene
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Gastroenteritis
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Groin abscess
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Herpes zoster
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Infection
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Influenza
|
0.43%
11/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.24%
6/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Intervertebral discitis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Joint abscess
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Kidney infection
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Localised infection
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Lyme disease
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Meningoencephalitis viral
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Neutropenic sepsis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Orchitis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Osteomyelitis
|
0.24%
6/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Osteomyelitis acute
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Otitis media chronic
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Paronychia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Perineal abscess
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Pneumonia
|
2.0%
50/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
3.0%
74/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Pneumonia aspiration
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Pneumonia bacterial
|
0.36%
9/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Pneumonia escherichia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Pneumonia legionella
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Post procedural infection
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Post procedural sepsis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Postoperative wound infection
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Rectal abscess
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Respiratory tract infection
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Rocky mountain spotted fever
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Sepsis
|
0.55%
14/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.92%
23/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Septic shock
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Serratia infection
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Staphylococcal osteomyelitis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Streptococcal sepsis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Tracheobronchitis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Urinary tract infection
|
0.55%
14/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.52%
13/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Urosepsis
|
0.28%
7/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Vestibular neuronitis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Wound infection
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Wound infection bacterial
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Wound sepsis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Aortic pseudoaneurysm
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Coronary artery reocclusion
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Crush injury
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Dislocation of sternum
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Dural tear
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.36%
9/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.40%
10/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Femoral nerve injury
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.24%
6/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Frostbite
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Graft haemorrhage
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.36%
9/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Intervertebral disc injury
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Pelvic organ injury
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Periprocedural myocardial infarction
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Post procedural hypotension
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Post procedural pulmonary embolism
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Radiation proctitis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.24%
6/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm ruptured
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Wound
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Investigations
International normalised ratio decreased
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Investigations
Respiratory syncytial virus test positive
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Investigations
Squamous cell carcinoma antigen
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Investigations
Transaminases increased
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Investigations
Troponin I increased
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Investigations
Troponin increased
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.24%
6/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.40%
10/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.32%
8/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.48%
12/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Gout
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Mineral deficiency
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Obesity
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.24%
6/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Back disorder
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.32%
8/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.32%
8/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.24%
6/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Knee impingement syndrome
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.36%
9/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.24%
6/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.24%
6/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
37/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
1.4%
36/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.32%
8/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.40%
10/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer metastatic
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign male reproductive tract neoplasm
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of ampulla of Vater
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign spleen tumour
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder adenocarcinoma stage unspecified
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.24%
6/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage I, with cancer in situ
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage I, without cancer in situ
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma metastatic
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma stage IV
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer metastatic
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glottis carcinoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage III
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal papilloma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.39%
10/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.24%
6/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage I
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage I
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.24%
6/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma stage III
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spinal cord
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular melanoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma stage III
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer stage II
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paget's disease of nipple
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage IV
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary cystadenoma lymphomatosum
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pelvic neoplasm
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile cancer
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phosphaturic mesenchymal tumour
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleomorphic adenoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Porocarcinoma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.71%
18/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.64%
16/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage IV
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal adenoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Syncope
|
0.75%
19/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.56%
14/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage II
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage IV
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage I
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer extensive stage
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue sarcoma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the hypopharynx
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma urethra
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer stage III
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Aphasia
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Axonal neuropathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Basilar artery stenosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Carotid artery disease
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.43%
11/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.40%
10/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Cerebral amyloid angiopathy
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Cerebral ataxia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Cerebral infarction
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.99%
25/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.80%
20/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Cognitive disorder
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Dementia
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Dizziness
|
0.32%
8/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Dizziness postural
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Embolic stroke
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Encephalopathy
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Epilepsy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Headache
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Hemianopia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Hemiparaesthesia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Hemiparesis
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.71%
18/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
1.1%
27/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Lacunar infarction
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Lacunar stroke
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Loss of consciousness
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Migraine
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Monoparesis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Moyamoya disease
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Paresis cranial nerve
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Parkinson's disease
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Peripheral nerve lesion
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Phantom limb syndrome
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Polyneuropathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Post stroke epilepsy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Presyncope
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Psychogenic seizure
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Sciatica
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Seizure
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Spinal cord compression
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Transient global amnesia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.43%
11/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.56%
14/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Vascular dementia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Vertebrobasilar stroke
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Product Issues
Device dislocation
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Product Issues
Device failure
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Product Issues
Device loosening
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Product Issues
Device malfunction
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Product Issues
Device mechanical issue
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Product Issues
Device occlusion
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Product Issues
Device power source issue
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Product Issues
Device stimulation issue
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Product Issues
Lead dislodgement
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Acute psychosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Alcohol abuse
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Anxiety
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Anxiety disorder due to a general medical condition
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Completed suicide
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Confusional state
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Depression
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Major depression
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Mania
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Mental status changes
|
0.36%
9/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Stress
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.99%
25/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
1.2%
30/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Bladder stenosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Calculus urinary
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.24%
6/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
End stage renal disease
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Haematuria
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.36%
9/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Obstructive nephropathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Renal colic
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Renal embolism
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Renal failure
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Renal haematoma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Renal impairment
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Renal mass
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Urethral perforation
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Urinary retention
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.36%
9/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.28%
7/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Pelvic organ prolapse
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Prostatic dysplasia
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Uterine inflammation
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.32%
8/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.92%
23/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.28%
7/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma late onset
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary disease
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.99%
25/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
1.2%
30/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.24%
6/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.36%
9/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic mass
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.47%
12/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.48%
12/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.51%
13/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.64%
16/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis herpetiformis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Ischaemic skin ulcer
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Neuropathic ulcer
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Surgical and medical procedures
Tissue expansion procedure
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Accelerated hypertension
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Aneurysm
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Aortic aneurysm
|
0.51%
13/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.40%
10/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Aortic stenosis
|
0.28%
7/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.40%
10/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Arterial perforation
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Arteriosclerosis
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.28%
7/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Blue toe syndrome
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.28%
7/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Diabetic macroangiopathy
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Dry gangrene
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Embolism arterial
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Extremity necrosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Femoral artery aneurysm
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Giant cell arteritis
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Haematoma
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Hypertension
|
0.79%
20/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.40%
10/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Hypertensive crisis
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Hypertensive emergency
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Hypertensive urgency
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Hypotension
|
0.28%
7/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Hypovolaemic shock
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Iliac artery embolism
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Iliac artery stenosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Intermittent claudication
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Internal haemorrhage
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Leriche syndrome
|
0.12%
3/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Lymphoedema
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.20%
5/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.20%
5/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.95%
24/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
1.0%
26/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.12%
3/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Peripheral circulatory failure
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Peripheral embolism
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Peripheral ischaemia
|
0.24%
6/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.40%
10/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.16%
4/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.40%
10/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Peripheral venous disease
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Shock
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Subclavian artery embolism
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Subclavian artery occlusion
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.04%
1/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Subclavian vein occlusion
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Superior vena cava stenosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Thrombophlebitis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Thrombosis
|
0.08%
2/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.16%
4/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Vena cava thrombosis
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Venous haemorrhage
|
0.04%
1/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.00%
0/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
0.08%
2/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
Other adverse events
| Measure |
Placebo in Parent Study
n=2532 participants at risk
Participants with Placebo in Parent Study
|
Evolocumab in Parent Study
n=2499 participants at risk
Participants with Evolocumab in Parent Study
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
6.4%
162/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
6.9%
173/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
157/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
6.2%
156/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.2%
208/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
6.5%
162/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.5%
139/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
5.4%
135/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
144/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
5.5%
138/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
133/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
5.5%
137/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
|
Vascular disorders
Hypertension
|
12.9%
327/2532 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
14.2%
355/2499 • Day 1 up to approximately 5 years during the OLE study.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of open-label evolocumab in the OLE study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER