Trial Outcomes & Findings for Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab (NCT NCT02304484)
NCT ID: NCT02304484
Last Updated: 2019-03-19
Results Overview
The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE. An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser \[AMD\]), including but not limited to, AEs resulting from insufficient or inadequate Instructions for Use, AEs resulting from any malfunction of the device, or AEs resulting from use error or from intentional misuse of the device.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
770 participants
Primary outcome timeframe
From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks.
Results posted on
2019-03-19
Participant Flow
This study was conducted at 126 centers in 29 countries in the regions of Europe, North America, Asia Pacific, and Latin America. Participants were enrolled from 24 November 2014 to 31 August 2016.
Participants who successfully completed week 80 of the parent Study 20120153 (NCT01813422) and did not discontinue study drug in the parent study for any reason were eligible for this study. All participants received open-label evolocumab.
Participant milestones
| Measure |
Evolocumab
Participants received 420 mg evolocumab once a month for up to 2 years.
|
|---|---|
|
Overall Study
STARTED
|
770
|
|
Overall Study
COMPLETED
|
745
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Evolocumab
Participants received 420 mg evolocumab once a month for up to 2 years.
|
|---|---|
|
Overall Study
Death
|
9
|
|
Overall Study
Withdrawal by Subject
|
14
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
Baseline characteristics by cohort
| Measure |
Evolocumab
n=770 Participants
Participants received 420 mg evolocumab once a month for up to 2 years.
|
|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Age, Customized
18 - 64 years
|
536 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
234 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
202 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
568 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
732 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
729 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
|
Low-density Lipoprotein Cholesterol (LDL-C) Concentration
|
92.2 mg/dL
STANDARD_DEVIATION 27.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks.Population: All enrolled participants
The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE. An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser \[AMD\]), including but not limited to, AEs resulting from insufficient or inadequate Instructions for Use, AEs resulting from any malfunction of the device, or AEs resulting from use error or from intentional misuse of the device.
Outcome measures
| Measure |
Evolocumab
n=770 Participants
Participants received 420 mg evolocumab once a month for up to 2 years.
|
|---|---|
|
Number of Participants With Adverse Events
Adverse events ≥ Grade 3
|
206 Participants
|
|
Number of Participants With Adverse Events
Fatal adverse events
|
6 Participants
|
|
Number of Participants With Adverse Events
Device-related adverse events ≥ Grade 2
|
2 Participants
|
|
Number of Participants With Adverse Events
Device-related adverse events ≥ Grade 3
|
1 Participants
|
|
Number of Participants With Adverse Events
Device-related adverse events ≥ Grade 4
|
0 Participants
|
|
Number of Participants With Adverse Events
Any adverse event
|
526 Participants
|
|
Number of Participants With Adverse Events
Adverse events ≥ Grade 2
|
415 Participants
|
|
Number of Participants With Adverse Events
Adverse events ≥ Grade 4
|
38 Participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
153 Participants
|
|
Number of Participants With Adverse Events
AEs leading to discontinuation of evolocumab
|
14 Participants
|
|
Number of Participants With Adverse Events
Device-related adverse events
|
12 Participants
|
|
Number of Participants With Adverse Events
Serious device-related adverse events
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128Population: Enrolled participants with available data at each time point
Outcome measures
| Measure |
Evolocumab
n=770 Participants
Participants received 420 mg evolocumab once a month for up to 2 years.
|
|---|---|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Percent change from baseline to week 0
|
-21.52 percent change
Standard Deviation 40.49
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Percent change from baseline to week 4
|
-57.23 percent change
Standard Deviation 22.19
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Percent change from baseline to week 12
|
-58.54 percent change
Standard Deviation 25.60
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Percent change from baseline to week 24
|
-55.26 percent change
Standard Deviation 28.51
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Percent change from baseline to week 36
|
-51.72 percent change
Standard Deviation 30.34
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Percent change from baseline to week 48
|
-53.65 percent change
Standard Deviation 28.72
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Percent change from baseline to week 52
|
-51.30 percent change
Standard Deviation 28.48
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Percent change from baseline to week 76
|
-51.73 percent change
Standard Deviation 32.49
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Percent change from baseline to week 104
|
-47.94 percent change
Standard Deviation 36.49
|
Adverse Events
Evolocumab
Serious events: 153 serious events
Other events: 49 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Evolocumab
n=770 participants at risk
Participants received 420 mg evolocumab once a month for up to 2 years.
|
|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.52%
4/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina pectoris
|
1.7%
13/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina unstable
|
0.65%
5/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
5/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial flutter
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac arrest
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure acute
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.39%
3/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery disease
|
0.52%
4/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Left ventricular failure
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial infarction
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Palpitations
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Pericarditis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Sinus bradycardia
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Sinus tachycardia
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vertigo
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Cataract
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Diplopia
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colitis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest discomfort
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest pain
|
0.52%
4/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Malaise
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Non-cardiac chest pain
|
0.78%
6/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Sudden death
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Vascular stent occlusion
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholangitis
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.39%
3/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Contrast media reaction
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Appendicitis
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bacterial colitis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Chronic sinusitis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Dengue fever
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diabetic foot infection
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diverticulitis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lung abscess
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lymph gland infection
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pertussis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.52%
4/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia bacterial
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Staphylococcal osteomyelitis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fall
|
0.39%
3/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Subarachnoid haematoma
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Gout
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.65%
5/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma metastatic
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to stomach
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to urinary tract
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Ischaemic stroke
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Parkinsonism
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Sciatica
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
0.39%
3/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Product Issues
Device loosening
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Suicidal ideation
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Haematuria
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal cyst
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.26%
2/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.52%
4/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Venous thrombosis
|
0.13%
1/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Evolocumab
n=770 participants at risk
Participants received 420 mg evolocumab once a month for up to 2 years.
|
|---|---|
|
Vascular disorders
Hypertension
|
6.4%
49/770 • Total deaths are reported from the 1st dose of evolocumab up to the end of study; adverse events are reported from the 1st dose of evolocumab up to 30 days after the last dose of study drug or end of study, whichever was earlier. The median (minimum, maximum) duration of treatment was 23.7 (0.4, 24.6) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
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