| Primary | Safety: Number of Participants With Any Severe Related Treatment-emergent Adverse Events (TEAEs) Per Infusion (Excluding Infections) | An Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. TEAEs were the AEs with onset after date-time of first dose of IP, or any medical condition present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. TEAEs that were recorded as "possibly related" or "probably related" to HYQVIA were considered HYQVIA-related adverse events. Number of participants with any severe related TEAEs (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | No | From start of study drug administration up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Primary | Safety: Rate of Any Severe Related TEAEs Per Infusion (Excluding Infections) | An AE was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. TEAEs were the AEs with onset after date-time of first dose of IP, or any medical condition present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. TEAEs that were recorded as "possibly related" or "probably related" to HYQVIA were considered HYQVIA-related adverse events. Severe related TEAEs rate per infusion was calculated as number of severe related TEAEs/total number of infusions administered to participants in the analysis set. Rate of any severe related TEAEs per infusion (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Number | | Number of Severe Related TEAEs/Infusion | | From start of study drug administration up to 20 months | Infusions | Infusions | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. |
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| Primary | Safety: Number of Participants With Any Related Serious TEAEs Per Infusion (Excluding Infections) | TEAEs were the AEs with onset after date-time of first dose of IP, or any medical condition present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs that were recorded as "possibly related" or "probably related" to HYQVIA were considered HYQVIA-related adverse events. Number of participants with any related serious TEAEs per infusion (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | No | From start of study drug administration up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. |
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| Primary | Safety: Rate of Any Related Serious TEAEs Per Infusion (Excluding Infections) | TEAEs were the AEs with onset after date-time of first dose of IP, or any medical condition present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in-patient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs that were recorded as "possibly related" or "probably related" to HYQVIA were considered HYQVIA-related adverse events. Rate of related serious TEAEs per infusion was calculated as number of related serious TEAEs/total number of infusions administered to participants in the analysis set. Rate of any related serious TEAEs per Infusion (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Number | | Number of Related Serious TEAEs/Infusion | | From start of study drug administration up to 20 months | Infusion | Infusion | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. |
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| Secondary | Efficacy: Change From Baseline in Total Serum Trough Levels of Immunoglobulin G (IgG) at Month 12 | Change from baseline in total serum trough levels of IgG in Epoch 1 and 2 was reported. Baseline was defined as the last non-missing value before the initial dose of HYQVIA. | Full analysis set included all participants who provide informed consent and meet enrollment eligibility. Here, "Overall number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Gram per liter (g/L) | | Baseline, Month 12 | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Efficacy: Change From Baseline in Serum Trough Levels of IgG Subclasses at Month 12 | Change from baseline in Serum trough levels of IgG subclasses 1, 2, 3, and 4 in Epoch 1 and 2 was reported. Baseline was defined as the last non-missing value before the initial dose of HYQVIA. | All participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, "Overall number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | g/L | | Baseline, Month 12 | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Efficacy: Change From Baseline in Trough Levels of Specific Antibodies to Clostridium Tetani Toxoid IgG at Month 12 | Change from baseline in trough levels of specific antibodies in clostridium tetani toxoid IgG at Month 12 was reported. Baseline was defined as the last non-missing value before the initial dose of HYQVIA. Here, IU/ml was defined as "International units per milliliter". | All participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, "Overall number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. Specific antibody data were not scheduled to be collected at Epoch 2 Month 0, so for most participants baseline could not be defined and change from baseline was not reported in HYQVIA Pre-treated arm. | Posted | | Mean | Standard Deviation | IU/ml | | Baseline, Month 12 | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | |
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| Secondary | Efficacy: Change From Baseline in Trough Levels of Specific Antibodies to Hepatitis B Virus (HBV) at Month 12 | Change from baseline in trough levels of specific antibodies in HBV at Month 12 was reported. Baseline was defined as the last non-missing value before the initial dose of HYQVIA. | All participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, "Overall number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. Specific antibody data were not scheduled to be collected at Epoch 2 Month 0, so for most participants baseline could not be defined and change from baseline was not reported in HYQVIA Pre-treated arm. | Posted | | Mean | Standard Deviation | International units per liter (IU/L) | | Baseline, Month 12 | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 |
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| Secondary | Efficacy: Change From Baseline in Trough Levels of Specific Antibodies to Haemophilus Influenzae B IgG at Month 12 | Change from baseline in trough levels of specific antibodies in Haemophilus influenzae B IgG at Month 12 was reported. Baseline was defined as the last non-missing value before the initial dose of HYQVIA. | All participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, "Overall number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. Specific antibody data were not scheduled to be collected at Epoch 2 Month 0, so for most participants baseline could not be defined and change from baseline was not reported in HYQVIA Pre-treated arm. | Posted | | Mean | Standard Deviation | Milligram per liter (mg/L) | | Baseline, Month 12 | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 |
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| Secondary | Safety: Percentage of Participants Who Achieved a Treatment Interval of Three or Four Weeks in Epoch 2 | Percentage of participants who achieved a treatment interval of three or four weeks in Epoch 2 was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Number | | Percentage of participants | | Up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Safety: Percentage of Participants Who Maintained a Treatment Interval of Three or Four Weeks in Epoch 2 up to 12 Months | Percentage of participants who maintained a treatment interval of three or four weeks in Epoch 2 up to 12 months was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Number | | Percentage of participants | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Safety: Number of Participants With Local TEAEs (Excluding Infections) | TEAEs were the AEs with onset after date-time of first dose of IP, or any medical condition present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. Number of Participants with local TEAEs (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | No | From start of study drug administration up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Safety: Rate of Local TEAEs Per Infusion (Excluding Infections) | Rate of local TEAEs per infusion was calculated as number of local adverse events/total number of infusions administered to participants in the analysis set. Only events are included which start prior to participants start date of non-response. Rate of local TEAEs per infusion (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Number | | Number of local TEAEs/Infusion | | From start of study drug administration up to 20 months | Infusion | Infusion | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Safety: Number of Participants With Local Adverse Reaction (Excluding Infections) | Adverse reaction was defined as any TEAE that meets any of the following criteria: 1) A TEAE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or; 2) A TEAE that begins during infusion of IP or within 72 hours following the end of IP infusion, or; 3) A TEAE for which causality assessment is missing or indeterminate. Number of participants with local adverse reactions (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | No | From start of study drug administration up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 |
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| Secondary | Safety: Rate of Local Adverse Reaction Per Infusion (Excluding Infections) | Rate of local adverse reaction per infusion was calculated as number of local adverse reaction events/total number of infusions administered to participants in the analysis set. Rate of local adverse reactions per infusion (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Number | | Number of Local AR events/Infusion | | From start of study drug administration up to 20 months | Infusion | Infusion | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Safety: Number of Participants With Systemic TEAEs (Excluding Infections) | TEAEs were the AEs with onset after date-time of first dose of IP, or any medical condition present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. Number of participants with systemic TEAEs (excluding infections) was reported.. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | No | From start of study drug administration up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Safety: Rate of Systemic TEAEs Per Infusion (Excluding Infections) | Rate of systemic TEAEs per infusion was calculated as number of systemic adverse events/total number of infusions administered to participants in the analysis set. Rate of systemic TEAEs per infusion was assessed based on events per infusion. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Number | | Number of systemic TEAEs/Infusion | | From start of study drug administration up to 20 months | Infusion | Infusion | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Safety: Number of Participants With Systemic Adverse Reaction (Excluding Infections) | Adverse reaction was defined as any TEAE that meets any of the following criteria: 1) A TEAE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or; 2) A TEAE that begins during infusion of IP or within 72 hours following the end of IP infusion, or; 3) A TEAE for which causality assessment is missing or indeterminate. Number of participants with systemic adverse reaction (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | No | From start of study drug administration up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 |
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| Secondary | Safety: Rate of Systemic Adverse Reaction Per Infusion (Excluding Infections) | Rate of Systemic adverse reactions per infusion was calculated as number of systemic adverse reaction events/total number of infusions administered to participants in the analysis set. Rate of systemic adverse reactions per infusion (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Number | | Number of systemic AR events/Infusion | | From start of study drug administration up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Safety: Number of Participants With Any TEAEs (Excluding Infections) | TEAEs were the AEs with onset after date-time of first dose of IP, or any medical condition present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. Number of participants with any TEAEs (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | No | From start of study drug administration up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Safety: Rate of TEAEs Per Infusion (Excluding Infections) | Rate of TEAEs per infusion was calculated as number of adverse events/total number of infusions administered to participants in the analysis set. Rate of TEAEs per infusion (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Number | | Number of TEAEs/Infusion | | From start of study drug administration up to 20 months | Infusion | Infusion | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Safety: Number of Participants With Any Adverse Reactions (Excluding Infections) | Adverse reaction was defined as any TEAE that meets any of the following criteria: 1) A TEAE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or; 2) A TEAE that begins during infusion of IP or within 72 hours following the end of IP infusion, or; 3) A TEAE for which causality assessment is missing or indeterminate. Number of participants with any adverse reactions (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | No | From start of study drug administration up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 |
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| Secondary | Safety: Rate of Any Adverse Reaction Per Infusion (Excluding Infections) | Rate of all adverse reactions per infusion was calculated as number of adverse reaction events/total number of infusions administered to participants in the analysis set. Rate of any adverse reactions per infusion (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Number | | Adverse reaction event/Infusion | | From start of study drug administration up to 20 months | Infusion | Infusion | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Safety: Number of Participants With Any Temporally Associated TEAEs (Excluding Infections) | Temporally-associated TEAEs were defined as TEAEs which begin during infusion of IP or within 72 hours following the end of IP infusion. Number of participants with any temporally associated TEAEs (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | No | From start of study drug administration up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Safety: Rate of Any Temporally Associated TEAEs Per Infusion (Excluding Infections) | Rate of any temporally associated TEAEs per infusion was calculated as number of temporally associated adverse events/total number of infusions administered to participants in the analysis set. Temporally-associated TEAEs were defined as TEAEs which begin during infusion of IP or within 72 hours following the end of IP infusion. Rate of any temporally associated TEAEs per infusion (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Number | | Temporally associated TEAEs/Infusion | | From start of study drug administration up to 20 months | Infusion | Infusion | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated |
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| Secondary | Safety: Number of Participants With Any Related (Causally) and/or Temporally Associated TEAEs (Excluding Infections) | Number of participants with any related (causally) and/or temporally associated TEAEs (excluding infections) was reported. Temporally-associated TEAEs were defined as TEAEs which begin during infusion of IP or within 72 hours following the end of IP infusion. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia | Posted | | Count of Participants | | Participants | No | From start of study drug administration up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Safety: Rate of Any Related (Causally) and/or Temporally Associated TEAEs Per Infusion (Excluding Infections) | Rate of any related (causally) and/or temporally associated TEAEs per infusion was calculated as number of related and/or temporally associated adverse events/ total number of infusions administered to participants in the analysis set. TEAEs recorded in the study database as "possibly related" or "probably related" to HYQVIA are considered HYQVIA-related adverse events. Temporally-associated TEAEs were defined as TEAEs which begin during infusion of IP or within 72 hours following the end of IP infusion. Rate of any related (causally) and/or temporally associated TEAEs per infusion (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Number | | Related Temporally TEAEs/Infusion | | From start of study drug administration up to 20 months | Infusion | Infusion | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. |
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| Secondary | Safety: Number of Participants With Any Serious TEAEs (Excluding Infections) | Serious TEAE were the AEs that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in-patient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Number of participants with any serious TEAEs (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | No | From start of study drug administration up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | |
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| Secondary | Safety: Rate of Serious TEAEs Per Infusion (Excluding Infections) | Rate of serious TEAEs per infusion was calculated as number of serious adverse events/total number of infusions administered to participants in the analysis set. Rate of serious TEAEs per infusion (excluding infections) was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Number | | Number of serious TEAEs/Infusion | | From start of study drug administration up to 20 months | Infusion | Infusion | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Safety: Number of Participants Who Developed Positive Titer (>=160) of Binding or Neutralizing Antibodies to rHuPH20 | Number of participants who developed positive titer (>=160) of binding or neutralizing antibodies to rHuPH20 was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | No | From start of study drug administration up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Other Analysis: Number of Infusions Per Month | Number of infusions per month was calculated as total number of infusions per duration of treatment (days) * 30.4 days per month. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Median | Full Range | Infusion/Month | | Up to 20 months | Infusions | Infusions | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Other Analysis: Number of Infusion Sites (Needle-Sticks) Per Infusion | Number of infusion sites (needle-sticks) per infusion was calculated as total number of infusion sites / total number of infusions. Only infusions with complete data available were included. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Mean | Standard Deviation | Infusion sites (needle sticks)/Infusion | | Up to 20 months | infusion | infusion | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Other Analysis: Number of Infusion Sites (Needle-Sticks) Per Month | Number of infusion sites per month was calculated as total number of infusion sites / duration of treatment (days) * 30.4 days. Only infusions with complete data available were included. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Mean | Standard Deviation | Infusion sites (needle sticks)/Month | | Up to 20 months | infusion | infusion | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Other Analysis: Duration of Infusion | The duration of infusion was defined as the difference between the end time and the start time of the HyQvia infusion. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Median | Full Range | Minutes | | From start of study drug administration up to 20 months. | Infusions | Infusions | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Other Analysis: Maximum Infusion Rate Per Site | Maximum infusion rate per site was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Mean | Standard Deviation | Milliliter per hour per site (mL/h/site) | | Up to 20 months | Infusions | Infusions | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Other Analysis: Infusion Volume Per Site | Infusion volume per site was calculated as actual IgG volume (milliliter [mL]) / total number of infusion sites (hour) used. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Mean | Standard Deviation | Milliliter per hour | | Up to 20 months | Infusions | Infusions | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Other Analysis: Number of Infusions That Were Interrupted or Stopped Due to an AE | Number of infusions that were interrupted or Stopped due to an AE was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Posted | | Number | | Infusions | | Up to 20 months | Infusions | Infusions | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Other Analysis: Number of Weeks to Reach Final 3 or 4-week Dose Interval in Epoch 1 | Final dose interval, defined as three or four weeks infusion interval in Epoch 1 of treatment period, was reported. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, "Overall number of Participants Analyzed" signifies participants who are evaluable for this outcome measure. Data collection and analysis was not planned for HyQvia pre-treated group. | Posted | | Median | Full Range | Weeks | | Up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. | | OG001 | HyQvia Pre-treated | Participants already treated with HYQVIA by the time of enrollment were directly enrolled in Epoch 2 and treated with HyQvia SC at every 3 or 4 weeks for up to 20 months. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment with a dosage frequency of once every three or four weeks, based on the participants previous dosing schedule and the discretion of the investigator and participant. |
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| Secondary | Health Related Quality of Life (HR QoL): Change From Baseline in Pediatric Quality of Life Questionnaire (PedsQL) | PedsQL Generic Core Scale (GCS) was used for QOL assessment. It encompasses 4 dimensions (physical functioning [PF], emotional functioning [EF], social functioning [SF], school functioning [ScF]). Age groups are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Teens (13-<18 years). Depending on the participants age, the questionnaire may be completed by either the participant or the parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young child, and a 5-point Likert scale for the child and teens groups. All Scores were transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate better quality of life. A negative change from baseline indicates worse quality of life. Baseline: last non-missing value before the initial dose of HYQVIA. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, "Overall number of Participants Analyzed" signifies participants who are evaluable for this outcome measure and "Number analyzed" signifies participants who are evaluable for this outcome at specific time point. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. |
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| Secondary | HRQoL: Change From Baseline in EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) | EQ-5D considered five attributes of quality of life evaluation, that is, mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension had five possible levels: 1 (no problems); 2 (slight problems); 3 (moderate problems); 4 (severe problems), and; 5 (extreme problems). The participants rating of their current HRQoL state was recorded using a standard vertical 20-cm visual analog scale (EQ-VAS), which ranged from 0 to 100, where 0 indicated worst imaginable health state and 100 was best imaginable health state. Baseline was defined as the last non-missing value before the initial dose of HYQVIA. A negative change from baseline indicates worse health state. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, "Overall number of Participants Analyzed" signifies participants who are evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. |
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| Secondary | HR QoL: Change From Baseline in Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) | TSQM-9 is a 9-item, validated, self-administered instrument to assess participants satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1)*3 items = 18 for the effectiveness and convenience, and (5-1)*3 items = 12 for global satisfaction . The item scores of each of the 3 domains are summed and transformed to create a score of 0 (extremely dissatisfied) to 100 (extremely satisfied). Higher score indicated greater satisfaction in that domain. A negative change from baseline indicates less satisfaction in that domain. Baseline was defined as the last non-missing value before the initial dose of HYQVIA. | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, "Overall number of Participants Analyzed" signifies participants who are evaluable for this outcome measure and "Number analyzed" signifies participants who are evaluable for this outcome at specific time point. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline up to 20 months | | | | ID | Title | Description |
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| OG000 | HyQvia New Starters | Participants who were treated with non-HyQvia treatment by time of enrollment were enrolled in Epoch 1 (ramp-up) and treated with HyQvia SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia dose was planned to be equivalent to 100% (±5%) of pre-study treatment. Dosage Frequency was one treatment interval of one week, then one treatment interval of two weeks, then one treatment interval of three weeks (for participants in whom treatment was expected to be every four weeks). The ramp-up period was followed by Epoch 2 (no ramp-up) with HyQvia SC treatment at every 3 or 4 weeks, depending on the participant's previous dosing schedule and the discretion of the investigator and participant, for up to 20 months. |
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