Trial Outcomes & Findings for Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia) (NCT NCT02624869)

Results Overview

An adverse event is defined as any untoward medical occurrence in a clinical trial participant, not necessarily having a causal relationship with study treatment. A serious AE is as an AE that met at least 1 of the following criteria: * fatal; * life threatening; * required in-patient hospitalization or prolongation of existing hospitalization; * resulted in persistent or significant disability/incapacity; * congenital anomaly/birth defect; * other medically important serious event. AEs were graded for severity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death related to AE.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

163 participants

Primary outcome timeframe

From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks.

Results posted on

2024-05-29

Participant Flow

This study was conducted at 46 centers in 23 countries (Australia, Austria, Belgium, Brazil, Canada, Colombia, Czech Republic, Greece, Hungary, Italy, Malaysia, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Kingdom, and United States of America).

This study enrolled participants with heterozygous familial hypercholesterolemia (HeFH) who had completed the parent study 20120123 (NCT02392559) without experiencing a treatment-related serious adverse event, and children 10 to 17 years of age with a diagnosis of homozygous familial hypercholesterolemia (HoFH).

Participant milestones

Participant milestones
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM Participants with heterozygous familial hypercholesterolemia (HeFH) who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Overall Study STARTED	49	101	13
Overall Study Received Study Drug	49	101	12
Overall Study COMPLETED	48	98	11
Overall Study NOT COMPLETED	1	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM Participants with heterozygous familial hypercholesterolemia (HeFH) who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Overall Study Lost to Follow-up	0	0	1
Overall Study Withdrawal by Subject	1	3	1

Baseline Characteristics

The full analysis set included all participants with HeFH from parent Study 20120123 who were enrolled and dosed as well as all participants with HoFH who were enrolled and dosed in this study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=49 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=101 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=13 Participants Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	Total n=163 Participants Total of all reporting groups
Region North America	8 Participants n=49 Participants	12 Participants n=101 Participants	0 Participants n=13 Participants	20 Participants n=163 Participants
Region Europe	33 Participants n=49 Participants	65 Participants n=101 Participants	7 Participants n=13 Participants	105 Participants n=163 Participants
Region Latin America	8 Participants n=49 Participants	18 Participants n=101 Participants	0 Participants n=13 Participants	26 Participants n=163 Participants
Region Asia Pacific	0 Participants n=49 Participants	6 Participants n=101 Participants	6 Participants n=13 Participants	12 Participants n=163 Participants
Age, Continuous	13.8 years STANDARD_DEVIATION 2.5 • n=49 Participants	14.2 years STANDARD_DEVIATION 2.4 • n=101 Participants	12.4 years STANDARD_DEVIATION 2.0 • n=13 Participants	14.0 years STANDARD_DEVIATION 2.5 • n=163 Participants
Age, Customized 2 - 11 years	11 Participants n=49 Participants	18 Participants n=101 Participants	6 Participants n=13 Participants	35 Participants n=163 Participants
Age, Customized 12 - 17 years	37 Participants n=49 Participants	76 Participants n=101 Participants	7 Participants n=13 Participants	120 Participants n=163 Participants
Age, Customized 18 - 64 years	1 Participants n=49 Participants	7 Participants n=101 Participants	0 Participants n=13 Participants	8 Participants n=163 Participants
Sex: Female, Male Female	24 Participants n=49 Participants	59 Participants n=101 Participants	2 Participants n=13 Participants	85 Participants n=163 Participants
Sex: Female, Male Male	25 Participants n=49 Participants	42 Participants n=101 Participants	11 Participants n=13 Participants	78 Participants n=163 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=49 Participants	6 Participants n=101 Participants	0 Participants n=13 Participants	13 Participants n=163 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=49 Participants	95 Participants n=101 Participants	13 Participants n=13 Participants	150 Participants n=163 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=49 Participants	0 Participants n=101 Participants	0 Participants n=13 Participants	0 Participants n=163 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=49 Participants	0 Participants n=101 Participants	0 Participants n=13 Participants	0 Participants n=163 Participants
Race/Ethnicity, Customized Asian	0 Participants n=49 Participants	2 Participants n=101 Participants	2 Participants n=13 Participants	4 Participants n=163 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=49 Participants	2 Participants n=101 Participants	0 Participants n=13 Participants	2 Participants n=163 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=49 Participants	0 Participants n=101 Participants	0 Participants n=13 Participants	0 Participants n=163 Participants
Race/Ethnicity, Customized White	40 Participants n=49 Participants	86 Participants n=101 Participants	9 Participants n=13 Participants	135 Participants n=163 Participants
Race/Ethnicity, Customized Other	9 Participants n=49 Participants	11 Participants n=101 Participants	2 Participants n=13 Participants	22 Participants n=163 Participants
Low-density Lipoprotein Cholesterol (LDL-C) Concentration	184.0 mg/dL STANDARD_DEVIATION 48.3 • n=49 Participants • The full analysis set included all participants with HeFH from parent Study 20120123 who were enrolled and dosed as well as all participants with HoFH who were enrolled and dosed in this study.	184.4 mg/dL STANDARD_DEVIATION 45.2 • n=101 Participants • The full analysis set included all participants with HeFH from parent Study 20120123 who were enrolled and dosed as well as all participants with HoFH who were enrolled and dosed in this study.	426.0 mg/dL STANDARD_DEVIATION 166.4 • n=12 Participants • The full analysis set included all participants with HeFH from parent Study 20120123 who were enrolled and dosed as well as all participants with HoFH who were enrolled and dosed in this study.	202.2 mg/dL STANDARD_DEVIATION 88.8 • n=162 Participants • The full analysis set included all participants with HeFH from parent Study 20120123 who were enrolled and dosed as well as all participants with HoFH who were enrolled and dosed in this study.
Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) Concentration	201.0 mg/dL STANDARD_DEVIATION 49.3 • n=49 Participants • Full analysis set	203.4 mg/dL STANDARD_DEVIATION 47.5 • n=101 Participants • Full analysis set	443.7 mg/dL STANDARD_DEVIATION 170.8 • n=12 Participants • Full analysis set	220.5 mg/dL STANDARD_DEVIATION 90.2 • n=162 Participants • Full analysis set
Apolipoprotein B (ApoB) Concentration	119.1 mg/dL STANDARD_DEVIATION 28.1 • n=47 Participants • Full analysis set with available baseline data	123.1 mg/dL STANDARD_DEVIATION 27.4 • n=100 Participants • Full analysis set with available baseline data	250.1 mg/dL STANDARD_DEVIATION 84.9 • n=12 Participants • Full analysis set with available baseline data	131.5 mg/dL STANDARD_DEVIATION 48.6 • n=159 Participants • Full analysis set with available baseline data
Total Cholesterol/High-density Lipoprotein Cholesterol (HDL-C) Ratio	5.546 ratio STANDARD_DEVIATION 1.541 • n=49 Participants • Full analysis set with available baseline data	5.716 ratio STANDARD_DEVIATION 1.809 • n=101 Participants • Full analysis set with available baseline data	14.707 ratio STANDARD_DEVIATION 7.891 • n=12 Participants • Full analysis set with available baseline data	6.331 ratio STANDARD_DEVIATION 3.557 • n=162 Participants • Full analysis set with available baseline data
Apolipoprotein B/Apolipoprotein A1 Ratio	0.943 ratio STANDARD_DEVIATION 0.265 • n=47 Participants • Full analysis set with available baseline data	0.972 ratio STANDARD_DEVIATION 0.306 • n=100 Participants • Full analysis set with available baseline data	2.388 ratio STANDARD_DEVIATION 1.036 • n=12 Participants • Full analysis set with available baseline data	1.070 ratio STANDARD_DEVIATION 0.545 • n=159 Participants • Full analysis set with available baseline data

PRIMARY outcome

Timeframe: From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks.

Population: Full analysis set

An adverse event is defined as any untoward medical occurrence in a clinical trial participant, not necessarily having a causal relationship with study treatment. A serious AE is as an AE that met at least 1 of the following criteria: * fatal; * life threatening; * required in-patient hospitalization or prolongation of existing hospitalization; * resulted in persistent or significant disability/incapacity; * congenital anomaly/birth defect; * other medically important serious event. AEs were graded for severity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death related to AE.

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=49 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=101 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=12 Participants Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any treatment-emergent adverse event (TEAE)	36 Participants	69 Participants	7 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) TEAE ≥ Grade 2	25 Participants	56 Participants	5 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) TEAE ≥ Grade 3	4 Participants	2 Participants	2 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) TEAE ≥ Grade 4	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Serious adverse events	2 Participants	2 Participants	2 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) TEAE leading to discontinuation of evolocumab	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Fatal adverse events	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HeFH participants baseline was defined as the baseline value of the parent study 20120123.

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=40 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=88 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HeFH Participants	-36.01 percent change Standard Error 4.28	-34.96 percent change Standard Error 3.05	—

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=11 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HoFH Participants	-14.29 percent change Interval -40.61 to 3.54	—	—

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HeFH participants baseline was defined as the baseline value of the parent study 20120123.

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=40 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=88 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Percent Change From Baseline to Week 80 in Non-HDL-C in HeFH Participants	-32.37 percent change Standard Error 3.96	-31.95 percent change Standard Error 2.89	—

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=11 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Percent Change From Baseline to Week 80 in Non-HDL-C in HoFH Participants	-13.03 percent change Interval -40.68 to 2.69	—	—

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HeFH participants baseline was defined as the baseline value in the parent study 20120123.

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=44 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=87 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Percent Change From Baseline to Week 80 in Apolipoprotein B in HeFH Participants	-27.10 percent change Standard Error 3.32	-24.15 percent change Standard Error 2.99	—

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=11 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Percent Change From Baseline to Week 80 in Apolipoprotein B in HoFH Participants	-19.17 percent change Interval -33.33 to 11.59	—	—

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HeFH participants baseline was defined as the baseline value in the parent study 20120123.

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=40 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=88 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HeFH Participants	-28.78 percent change Standard Error 3.48	-28.32 percent change Standard Error 2.47	—

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=11 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HoFH Participants	3.71 percent change Interval -41.17 to 7.57	—	—

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HeFH participants baseline was defined as the baseline value in the parent study 20120123.

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=44 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=87 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Percent Change From Baseline to Week 80 in Apolipoprotein B / Apolipoprotein A1 Ratio in HeFH Participants	-31.00 percent change Standard Error 3.66	-29.89 percent change Standard Error 2.80	—

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=11 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Percent Change From Baseline to Week 80 in Apolipoprotein B/Apolipoprotein A1 Ratio in HoFH Participants	-2.96 percent change Interval -35.71 to 9.3	—	—

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HeFH participants baseline was defined as the baseline value of the parent study 20120123.

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=40 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=88 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Change From Baseline to Week 80 in LDL-C in HeFH Participants	-67.2 mg/dL Standard Error 8.2	-63.1 mg/dL Standard Error 5.6	—

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HoFH participants baseline was defined as the baseline value in this study (20120124).

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=11 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Change From Baseline to Week 80 in LDL-C in HoFH Participants	-36.5 mg/dL Interval -180.5 to 16.0	—	—

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set; female participants with available data

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=23 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=54 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=2 Participants Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Change From Baseline to Week 80 in Estradiol Levels	131.3 pmol/L Standard Error 45.3	48.2 pmol/L Standard Error 58.1	283.0 pmol/L Standard Error 130.0

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set; male participants with available data

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=18 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=34 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=7 Participants Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Change From Baseline to Week 80 in Testosterone Levels	5.282 nmol/L Standard Error 1.567	3.230 nmol/L Standard Error 1.167	2.916 nmol/L Standard Error 0.984

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=44 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=91 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=10 Participants Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Change From Baseline to Week 80 in Follicle Stimulating Hormone (FSH) Levels	1.88 IU/L Standard Error 0.90	0.60 IU/L Standard Error 0.37	1.18 IU/L Standard Error 0.35

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=44 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=92 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=10 Participants Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Change From Baseline to Week 80 in Luteinizing Hormone (LH) Levels	2.88 IU/L Standard Error 1.51	1.04 IU/L Standard Error 0.95	1.76 IU/L Standard Error 0.84

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=43 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=84 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=11 Participants Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Change From Baseline to Week 80 in Adenocorticotropic Hormone (ACTH) Levels	0.78 pmol/L Standard Error 0.55	0.55 pmol/L Standard Error 0.61	-0.75 pmol/L Standard Error 1.79

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=43 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=89 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=11 Participants Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Change From Baseline to Week 80 in Dehydroepiandrosterone Sulfate (DHEA-S) Levels	1.051 μmol/L Standard Error 0.222	0.956 μmol/L Standard Error 0.126	0.944 μmol/L Standard Error 0.247

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124).

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=43 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=90 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=11 Participants Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Change From Baseline to Week 80 in Cortisol Levels	29.81 nmol/L Standard Error 28.34	51.18 nmol/L Standard Error 25.19	57.26 nmol/L Standard Error 56.11

SECONDARY outcome

Timeframe: Week 80

Population: Full analysis set with available data at week 80

Liver function tests included alanine aminotransferase (ALT) levels, aspartate aminotransferase (AST) levels and total bilirubin levels.

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=45 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=91 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=10 Participants Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Number of Participants With Liver Function Test Abnormalities at Week 80 Total bilirubin > 2 x ULN	0 Participants	2 Participants	1 Participants
Number of Participants With Liver Function Test Abnormalities at Week 80 ALT or AST > 3 x ULN	0 Participants	0 Participants	0 Participants
Number of Participants With Liver Function Test Abnormalities at Week 80 ALT or AST > 5 x ULN	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 80

Population: Full analysis set with available data at week 80

The number of participants with levels of creatine kinase greater than 5 times the upper limit of normal (ULN) and greater than 10 times the ULN, measured by the central laboratory.

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=45 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=90 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=10 Participants Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Number of Participants With Abnormalities in Levels of Creatine Kinase (CK) at Week 80 CK > 5 x ULN	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormalities in Levels of Creatine Kinase (CK) at Week 80 CK > 10 x ULN	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

Carotid intima-media thickness measures the thickness of the intima and media, the inner two layers of the carotid artery, and is used to determine the extent of plaque buildup in the walls of the arteries (atherosclerosis) supplying blood to the head. CIMT was measured by ultrasonography and analyzed at a core laboratory. The largest values measured in the left common carotid artery (LCCA) and the right common carotid artery (RCCA) are averaged in this analysis.

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=34 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=59 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=7 Participants Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Change From Baseline to Week 80 in Carotid Intima-media Thickness (cIMT)	-0.019 mm Standard Error 0.007	-0.012 mm Standard Error 0.006	0.006 mm Standard Error 0.032

SECONDARY outcome

Timeframe: Baseline and weeks 24, 48, and 80

Population: Full analysis set with available data at each time point.

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=49 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=101 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=12 Participants Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Change From Baseline in Height at Weeks 24, 48, and 80 Females: Baseline	158.1 cm Standard Error 2.3	157.9 cm Standard Error 1.3	149.4 cm Standard Error 7.1
Change From Baseline in Height at Weeks 24, 48, and 80 Females: Change at week 24	2.8 cm Standard Error 0.7	2.0 cm Standard Error 0.4	1.6 cm Standard Error 1.1
Change From Baseline in Height at Weeks 24, 48, and 80 Females: Change at week 48	4.2 cm Standard Error 1.0	2.8 cm Standard Error 0.5	1.4 cm Standard Error 2.4
Change From Baseline in Height at Weeks 24, 48, and 80 Females: Change at week 80	4.0 cm Standard Error 1.7	3.4 cm Standard Error 0.7	2.4 cm Standard Error 3.9
Change From Baseline in Height at Weeks 24, 48, and 80 Males: Baseline	158.2 cm Standard Error 3.0	163.7 cm Standard Error 1.9	158.9 cm Standard Error 4.8
Change From Baseline in Height at Weeks 24, 48, and 80 Males: Change at week 24	3.4 cm Standard Error 0.5	3.8 cm Standard Error 0.5	3.8 cm Standard Error 0.8
Change From Baseline in Height at Weeks 24, 48, and 80 Males: Change at week 48	6.2 cm Standard Error 0.8	6.2 cm Standard Error 0.7	5.3 cm Standard Error 1.2
Change From Baseline in Height at Weeks 24, 48, and 80 Males: Change at week 80	9.3 cm Standard Error 1.5	9.0 cm Standard Error 1.1	9.2 cm Standard Error 1.6

SECONDARY outcome

Timeframe: Baseline and weeks 24, 48, and 80

Population: Full analysis set with available data at each time point

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=49 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=101 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=12 Participants Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Change From Baseline in Weight at Weeks 24, 48, and 80 Females: Baseline	52.8 kg Standard Error 2.9	57.0 kg Standard Error 2.0	42.7 kg Standard Error 1.3
Change From Baseline in Weight at Weeks 24, 48, and 80 Females: Change at week 24	3.3 kg Standard Error 0.8	2.3 kg Standard Error 0.6	3.4 kg Standard Error 2.1
Change From Baseline in Weight at Weeks 24, 48, and 80 Females: Change at week 48	4.3 kg Standard Error 1.1	3.5 kg Standard Error 0.7	4.7 kg Standard Error 5.3
Change From Baseline in Weight at Weeks 24, 48, and 80 Females: Change at week 80	5.6 kg Standard Error 1.3	5.2 kg Standard Error 0.8	5.5 kg Standard Error 4.2
Change From Baseline in Weight at Weeks 24, 48, and 80 Males: Baseline	54.1 kg Standard Error 3.6	61.0 kg Standard Error 3.2	51.7 kg Standard Error 4.9
Change From Baseline in Weight at Weeks 24, 48, and 80 Males: Change at week 24	4.4 kg Standard Error 0.9	4.6 kg Standard Error 0.7	4.6 kg Standard Error 0.9
Change From Baseline in Weight at Weeks 24, 48, and 80 Males: Change at week 48	6.8 kg Standard Error 1.3	7.4 kg Standard Error 1.0	7.6 kg Standard Error 1.2
Change From Baseline in Weight at Weeks 24, 48, and 80 Males: Change at week 80	10.9 kg Standard Error 1.6	11.2 kg Standard Error 1.4	10.6 kg Standard Error 2.3

SECONDARY outcome

Timeframe: Baseline and week 80

Population: Full analysis set with available data

Pubertal growth and sexual maturity was assessed separately for males and females using the 5 Tanner stages where stage 1 = prepubertal and stage 5 = mature. The number of participants with any change in Tanner Stage from baseline is reported.

Outcome measures

Outcome measures
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=45 Participants Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=91 Participants Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=11 Participants Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Number of Participants With Change in Tanner Staging From Baseline to Week 80 Males: Staging by genital size	13 Participants	20 Participants	6 Participants
Number of Participants With Change in Tanner Staging From Baseline to Week 80 Males: Staging by pubic hair	14 Participants	21 Participants	6 Participants
Number of Participants With Change in Tanner Staging From Baseline to Week 80 Females: Staging by breast development	11 Participants	27 Participants	1 Participants
Number of Participants With Change in Tanner Staging From Baseline to Week 80 Females: Staging by pubic hair	11 Participants	26 Participants	1 Participants

Adverse Events

HeFH (Placebo in Parent Study): Evolocumab 420 mg QM

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM

Serious events: 2 serious events

Other events: 45 other events

Deaths: 0 deaths

HoFH: Evolocumab 420 mg QM

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HeFH (Placebo in Parent Study): Evolocumab 420 mg QM n=49 participants at risk Participants with HeFH who had received placebo in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks (QM) for up to 80 weeks.	HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM n=101 participants at risk Participants with HeFH who had received evolocumab in the parent study received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.	HoFH: Evolocumab 420 mg QM n=12 participants at risk Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks.
Infections and infestations Appendicitis	0.00% 0/49 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/101 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	8.3% 1/12 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Appendicitis perforated	2.0% 1/49 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/101 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/12 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Peritonitis	2.0% 1/49 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/101 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/12 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Arteriovenous fistula aneurysm	0.00% 0/49 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/101 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	8.3% 1/12 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Wrist fracture	2.0% 1/49 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/101 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/12 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Headache	0.00% 0/49 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.99% 1/101 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/12 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Anorexia nervosa	0.00% 0/49 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.99% 1/101 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/12 • From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Other adverse events

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

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