| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. | | Posted | | Count of Participants | | Participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. | | OG002 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| | | Title | Denominators | Categories |
|---|
| Any treatment-emergent adverse event (TEAE) | | | | TEAE ≥ Grade 2 | |
| |
| Secondary | Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HeFH Participants | For HeFH participants baseline was defined as the baseline value of the parent study 20120123. | Full analysis set with available data | Posted | | Mean | Standard Error | percent change | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. |
| |
| Secondary | Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HoFH Participants | For HoFH participants baseline was defined as the baseline value in this study (20120124). | Full analysis set with available data | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| | |
| Secondary | Percent Change From Baseline to Week 80 in Non-HDL-C in HeFH Participants | For HeFH participants baseline was defined as the baseline value of the parent study 20120123. | Full analysis set with available data | Posted | | Mean | Standard Error | percent change | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. |
| |
| Secondary | Percent Change From Baseline to Week 80 in Non-HDL-C in HoFH Participants | For HoFH participants baseline was defined as the baseline value in this study (20120124). | Full analysis set with available data | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| | |
| Secondary | Percent Change From Baseline to Week 80 in Apolipoprotein B in HeFH Participants | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. | Full analysis set with available data | Posted | | Mean | Standard Error | percent change | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. |
| |
| Secondary | Percent Change From Baseline to Week 80 in Apolipoprotein B in HoFH Participants | For HoFH participants baseline was defined as the baseline value in this study (20120124). | Full analysis set with available data | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| | |
| Secondary | Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HeFH Participants | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. | Full analysis set with available data | Posted | | Mean | Standard Error | percent change | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. |
| |
| Secondary | Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HoFH Participants | For HoFH participants baseline was defined as the baseline value in this study (20120124). | Full analysis set with available data | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| | |
| Secondary | Percent Change From Baseline to Week 80 in Apolipoprotein B / Apolipoprotein A1 Ratio in HeFH Participants | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. | Full analysis set with available data | Posted | | Mean | Standard Error | percent change | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. |
| |
| Secondary | Percent Change From Baseline to Week 80 in Apolipoprotein B/Apolipoprotein A1 Ratio in HoFH Participants | For HoFH participants baseline was defined as the baseline value in this study (20120124). | Full analysis set with available data | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| | |
| Secondary | Change From Baseline to Week 80 in LDL-C in HeFH Participants | For HeFH participants baseline was defined as the baseline value of the parent study 20120123. | Full analysis set with available data | Posted | | Mean | Standard Error | mg/dL | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. |
| |
| Secondary | Change From Baseline to Week 80 in LDL-C in HoFH Participants | For HoFH participants baseline was defined as the baseline value in this study (20120124). | Full analysis set with available data | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| | |
| Secondary | Change From Baseline to Week 80 in Estradiol Levels | 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). | Full analysis set; female participants with available data | Posted | | Mean | Standard Error | pmol/L | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. | | OG002 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| |
| Secondary | Change From Baseline to Week 80 in Testosterone Levels | 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). | Full analysis set; male participants with available data | Posted | | Mean | Standard Error | nmol/L | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. | | OG002 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| |
| Secondary | Change From Baseline to Week 80 in Follicle Stimulating Hormone (FSH) Levels | 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). | Full analysis set with available data | Posted | | Mean | Standard Error | IU/L | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. | | OG002 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| |
| Secondary | Change From Baseline to Week 80 in Luteinizing Hormone (LH) Levels | 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). | Full analysis set with available data | Posted | | Mean | Standard Error | IU/L | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. | | OG002 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| |
| Secondary | Change From Baseline to Week 80 in Adenocorticotropic Hormone (ACTH) Levels | 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). | Full analysis set with available data | Posted | | Mean | Standard Error | pmol/L | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. | | OG002 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| |
| Secondary | Change From Baseline to Week 80 in Dehydroepiandrosterone Sulfate (DHEA-S) Levels | 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). | Full analysis set with available data | Posted | | Mean | Standard Error | μmol/L | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. | | OG002 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| |
| Secondary | Change From Baseline to Week 80 in Cortisol Levels | 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). | Full analysis set with available data | Posted | | Mean | Standard Error | nmol/L | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. | | OG002 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| |
| Secondary | Number of Participants With Liver Function Test Abnormalities at Week 80 | Liver function tests included alanine aminotransferase (ALT) levels, aspartate aminotransferase (AST) levels and total bilirubin levels. | Full analysis set with available data at week 80 | Posted | | Count of Participants | | Participants | | Week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. | | OG002 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| |
| Secondary | Number of Participants With Abnormalities in Levels of Creatine Kinase (CK) 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. | Full analysis set with available data at week 80 | Posted | | Count of Participants | | Participants | | Week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. | | OG002 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| |
| Secondary | Change From Baseline to Week 80 in Carotid Intima-media Thickness (cIMT) | 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. | Full analysis set with available data | Posted | | Mean | Standard Error | mm | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. | | OG002 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
|
| Secondary | Change From Baseline in Height at Weeks 24, 48, and 80 | | Full analysis set with available data at each time point. | Posted | | Mean | Standard Error | cm | | Baseline and weeks 24, 48, and 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. | | OG002 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| |
| Secondary | Change From Baseline in Weight at Weeks 24, 48, and 80 | | Full analysis set with available data at each time point | Posted | | Mean | Standard Error | kg | | Baseline and weeks 24, 48, and 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. | | OG002 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
| |
| Secondary | Number of Participants With Change in Tanner Staging From Baseline to Week 80 | 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. | Full analysis set with available data | Posted | | Count of Participants | | Participants | | Baseline and week 80 | | | | ID | Title | Description |
|---|
| OG000 | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 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. | | OG001 | 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. | | OG002 | HoFH: Evolocumab 420 mg QM | Participants with HoFH received 420 mg evolocumab administered by subcutaneous injection every 4 weeks for up to 80 weeks. |
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