| Primary | Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Alglucosidase Alfa | Cmax was defined as maximum observed plasma concentration. | Analysis was performed on all participants who received any amount of alglucosidase alfa. | Posted | | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Alglucosidase Alfa: <18 Years | Participants with <18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. | | OG001 | Alglucosidase Alfa: >=18 Years | Participants with >=18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000204000± 94600
- OG001307000± 143000
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| Primary | Pharmacokinetics: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alglucosidase Alfa | Tmax was defined as time to reach maximum observed plasma concentration. | Analysis was performed on all participants who received any amount of alglucosidase alfa. | Posted | | Median | Full Range | hours | | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Alglucosidase Alfa: <18 Years | Participants with <18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. | | OG001 | Alglucosidase Alfa: >=18 Years | Participants with >=18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. |
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| Primary | Pharmacokinetics: Area Under the Plasma Concentration-Time Curve (AUC) of Alglucosidase Alfa | AUC was defined as area under the plasma concentration-time curve from time 0 to 24 hours post-dose. | Analysis was performed on all participants who received any amount of alglucosidase alfa. | Posted | | Mean | Standard Deviation | hours per nanograms per milliliter | | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Alglucosidase Alfa: <18 Years | Participants with <18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. | | OG001 | Alglucosidase Alfa: >=18 Years | Participants with >=18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. |
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| Primary | Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Alglucosidase Alfa | AUC0-last was defined as area under the concentration-time curve from time 0 to the time of the last quantifiable concentration. | Analysis was performed on all participants who received any amount of alglucosidase alfa. | Posted | | Mean | Standard Deviation | hours per nanograms per milliliter | | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Alglucosidase Alfa: <18 Years | Participants with <18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. | | OG001 | Alglucosidase Alfa: >=18 Years | Participants with >=18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. |
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| Primary | Pharmacokinetics: Terminal Elimination Half-life (T1/2) of Alglucosidase Alfa | T1/2 was defined as the time taken by drug to reduce to half of its initial plasma concentration. | Analysis was performed on all participants who received any amount of alglucosidase alfa. | Posted | | Mean | Standard Deviation | hours | | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Alglucosidase Alfa: <18 Years | Participants with <18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. | | OG001 | Alglucosidase Alfa: >=18 Years | Participants with >=18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. |
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| Primary | Pharmacokinetics: Total Systemic Clearance (CL) of Alglucosidase Alfa | CL of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | Analysis was performed on all participants who received any amount of alglucosidase alfa. | Posted | | Mean | Standard Deviation | Liters per hour | | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Alglucosidase Alfa: <18 Years | Participants with <18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. | | OG001 | Alglucosidase Alfa: >=18 Years | Participants with >=18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. |
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| Primary | Pharmacokinetics: Volume of Distribution at Steady State (Vss) of Alglucosidase Alfa | Volume of distribution (Vd) is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss is the apparent volume of distribution at steady-state. | Analysis was performed on all participants who received any amount of alglucosidase alfa. | Posted | | Mean | Standard Deviation | Liters | | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Alglucosidase Alfa: <18 Years | Participants with <18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. | | OG001 | Alglucosidase Alfa: >=18 Years | Participants with >=18 years of age received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. |
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| Secondary | Pharmacokinetics: Maximum Observed Plasma Concentration of Alglucosidase Alfa in Anti-Recombinant Human Acid Alpha-Glucosidase Antibody Positive and Negative Participants | Cmax was defined as maximum observed plasma concentration. | Analysis was performed on FAS that included all participants who received any amount of alglucosidase alfa. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Anti-rhGAA Antibody Negative Participants | Participants with negative anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. | | OG001 | Anti-rhGAA Antibody Positive Participants | Participants with positive anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. |
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| Secondary | Pharmacokinetics: Time to Reach Maximum Observed Plasma Concentration in Anti-rhGAA Antibody Positive and Negative Participants | Tmax was defined as time to reach maximum observed plasma concentration. | Analysis was performed on FAS that included all participants who received any amount of alglucosidase alfa. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Posted | | Median | Full Range | hours | | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Anti-rhGAA Antibody Negative Participants | Participants with negative anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. | | OG001 | Anti-rhGAA Antibody Positive Participants | Participants with positive anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. |
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| Secondary | Pharmacokinetics: Terminal Elimination Half-life of Alglucosidase Alfa in Anti-rhGAA Antibody Positive and Negative Participants | T1/2 was defined as the time taken by drug to reduce to half of its initial plasma concentration. | Analysis was performed on FAS that included all participants who received any amount of alglucosidase alfa. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | hours | | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Anti-rhGAA Antibody Negative Participants | Participants with negative anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. | | OG001 | Anti-rhGAA Antibody Positive Participants | Participants with positive anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. |
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| Secondary | Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alglucosidase Alfa in Anti-rhGAA Antibody Positive and Negative Participants | AUC0-last was defined as area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. | Analysis was performed on FAS that included all participants who received any amount of alglucosidase alfa. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | hours per nanograms per milliliter | | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Anti-rhGAA Antibody Negative Participants | Participants with negative anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. | | OG001 | Anti-rhGAA Antibody Positive Participants | Participants with positive anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. |
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| Secondary | Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 and Extrapolated to Infinite Time (AUC0-inf) in Anti-rhGAA Antibody Positive and Negative Participants | AUC0-inf was defined as area under the concentration-time curve from time 0 extrapolated to infinite time. | Analysis was performed on FAS that included all participants who received any amount of alglucosidase alfa. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | hours per nanograms per milliliter | | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Anti-rhGAA Antibody Negative Participants | Participants with negative anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. | | OG001 | Anti-rhGAA Antibody Positive Participants | Participants with positive anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. |
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| Secondary | Pharmacokinetics: Total Systemic Clearance in Anti-rhGAA Antibody Positive and Negative Participants | CL of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | Analysis was performed on FAS that included all participants who received any amount of alglucosidase alfa. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | Liters per hour | | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Anti-rhGAA Antibody Negative Participants | Participants with negative anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. | | OG001 | Anti-rhGAA Antibody Positive Participants | Participants with positive anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. |
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| Secondary | Pharmacokinetics: Volume of Distribution in Anti-rhGAA Antibody Positive and Negative Participants | Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss is the apparent volume of distribution at steady-state. | Analysis was performed on FAS that included all participants who received any amount of alglucosidase alfa. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | Liters | | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | | | | ID | Title | Description |
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| OG000 | Anti-rhGAA Antibody Negative Participants | Participants with negative anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. | | OG001 | Anti-rhGAA Antibody Positive Participants | Participants with positive anti-rhGAA IgG antibody status at Baseline received IV infusion of Alglucosidase alfa 20 mg/kg body weight on Day 1. Infusion was administered at an initial rate of approximately 1 mg/kg/hr with allowed rate increased of 2 mg/kg/hr every 30 minutes, if there were no signs of IARs, until a maximum rate of approximately 7 mg/kg/hr was reached. |
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