| Primary | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | An AE is any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. AEs include serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of special interest (AESI). AESI include local injection site reactions, general allergic events, elevated alanine aminotransferase (ALT) levels greater than or equal to (≥) 3 upper limit normal (ULN) (if baseline is less than (<) ULN)/ALT ≥2 x ULN (if baseline ≥ ULN), neurologic events, neurocognitive events (according to Customized Medical Dictionary for Regulatory Activities [MedDRA] Query [CMQ] by Sponsor grouping and CMQ by FDA grouping), cataract, new onset diabetes (NOD), hepatic disorders, and diabetes mellitus (DM)/diabetic complications. | Safety analysis set (SAF): All participants who received any study drug | Posted | | Number | | Participants | | After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks | | | | ID | Title | Description |
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| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
| | | Title | Denominators | Categories |
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| Any treatment emergent adverse event (TEAE) | | | | Any treatment emergent serious adverse event (SAE) | |
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| Secondary | Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | Milligrams per decilitre (mg/dL) | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Percent Change in LDL-C From Baseline Over Time | | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | Percent Change | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Total Cholesterol (Total-C) Values From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | mg/dL | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Percent Change From Baseline in Total-C Over Time | | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | Percent Change | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Lipoprotein a (Lp(a)) Values From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | mg/dL | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Percent Change From Baseline in Lp(a) Over Time | | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | Percent Change | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | mg/dL | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Percent Change From Baseline in Non-HDL-C Over Time | | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | Percent Change | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | mg/dL | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Percent Change From Baseline in HDL-C Over Time | | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | Percent Change | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Fasting Triglycerides (TGs) Values From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | mg/dL | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Percent Change From Baseline in Fasting TGs Over Time | | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | Percent Change | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Apolipoprotein B (Apo B) Values From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | mg/dL | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Percent Change From Baseline in Apo B Over Time | | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | Percent Change | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | mg/dL | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Percent Change From Baseline in Apo A1 Over Time | | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | Percent Change | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (Female participants who received any study drug); Here, "Number Analyzed" = Number of female participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | International units per litre (IU/L) | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time | | SAF (Female participants who received any study drug); Here, "Number Analyzed" = Number of female participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | IU/L | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (Male participants who received any study drug); Here, "Number Analyzed" = Number of male participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | International units per litre (IU/L) | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time | | SAF (Male participants who received any study drug); Here, "Number Analyzed" = Number of male participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | IU/L | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (Female participants who received any study drug); Here, "Number Analyzed" = Number of female participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | picomoles per litre (pmol/L) | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time | | SAF (Female participants who received any study drug); Here, "Number Analyzed" = Number of female participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | pmol/L | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (Male participants who received any study drug); Here, "Number Analyzed" = Number of male participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | nanomoles per litre (nmol/L) | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time | | SAF (Male participants who received any study drug); Here, "Number Analyzed" = Number of male participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | nmol/L | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Alanine Aminotransferase Values From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | U/L (Units per Liter) | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Change From Baseline in Alanine Aminotransferase Over Time | | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | U/L | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Aspartate Aminotransferase Values From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | U/L | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Change From Baseline in Aspartate Aminotransferase Over Time | | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | U/L | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Alkaline Phosphatase Values From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | U/L | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Change From Baseline in Alkaline Phosphatase Over Time | | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | U/L | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Total Bilirubin Values From Baseline Over Time | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | micromoles per litre (umol/L) | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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| Secondary | Change From Baseline in Total Bilirubin Over Time | | SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint | Posted | | Mean | Standard Deviation | umol/L | | Up to week 72 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 Q2W/Up150 Q2W | All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. |
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