| Primary | Rate Represented as Mean Number of Acute Serious Bacterial Infections (ASBI) Per Participant-year | The rate of ASBI was defined as the mean number of ASBI per participant-year based on the United States (U.S.) Food and drugs Administration (FDA) guidance for industry to support marketing of human immune globulin intravenous (IGIV) as replacement therapy for primary humoral immunodeficiency and the European Medicines Agency (EMA) guideline on the clinical investigation of human normal immunoglobulin for SC and /or intramuscular administration. ASBI included bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess, diagnosed according to the Diagnostic Criteria for Acute Serious Bacterial Infections. | FAS included all participants who provided informed consent, and met enrollment eligibility. | Posted | | Mean | Standard Error | ASBI per participant-year | | From first dose of study drug up to end of Study Epoch 2 (up to approximately 37.2 months) | | | | ID | Title | Description |
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| OG000 | Epoch 1 + Epoch 2 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Rate Represented as Mean Number of All Infections Per Participant-year | The rate of all infections was defined as the mean number of all infections per participant-year. Number of all infections was calculated as number of infections per participant-year. | FAS included all participants who provided informed consent, and met enrollment eligibility. | Posted | | Mean | Standard Error | infections per participant-year | | From first dose of study drug up to end of Study Epoch 2 (up to approximately 37.2 months) | | | | ID | Title | Description |
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| OG000 | Epoch 1 + Epoch 2 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Trough Levels of Immunoglobulin G (IgG) Total and IgG Subclasses | | FAS=all participants who provided informed consent, and met enrollment eligibility. Only FAS participants in Epoch 2 were analyzed for this outcome measure. Overall number analyzed=number of participants with data available for analyses. Number analyzed=number of participants with data available for analysis at specified timepoint. | Posted | | Mean | Standard Deviation | grams per liter (g/L) | | Study Epoch 2, Year 1: Months 0, 6, and 12; Year 2: Months 18, 24 and 36 | | | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Trough Levels of Specific Antibodies to Clinically Relevant Pathogens Categorized as Clostridium Tetani Toxoid and Hepatitis B Virus | | FAS=all participants who provided informed consent, and met enrollment eligibility. Only FAS participants in Epoch 2 were analyzed for this outcome measure. Overall number analyzed=number of participants with data available for analyses. Number analyzed=number of participants with data available for analysis at specified timepoint. | Posted | | Mean | Standard Deviation | international unit per milliliter(IU/mL) | | Study Epoch 2, Year 2: Months 6, 24, and 36 | | | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Trough Levels of Specific Antibodies to Clinically Relevant Pathogen Haemophilus Influenzae B | | FAS=all participants who provided informed consent, and met enrollment eligibility. Only FAS participants in Epoch 2 were analyzed for this outcome measure. Overall number analyzed=number of participants with data available for analyses. Number analyzed=number of participants with data available for analysis at specified timepoint. | Posted | | Mean | Standard Deviation | milligrams per liter (mg/L) | | Study Epoch 2, Year 2: Months 6, 24, and 36 | | | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Area Under the Curve Normalized for Week (AUCweek) | | Pharmacokinetic analysis set (PKAS) included all participants in the Safety Analysis Set who have at least 1 evaluable post-dose concentration data for PK assessments without major protocol deviations or events affecting the PK results. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in statistical analysis plan (SAP), this outcome measure was planned only for Epoch 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | grams*day per liter (g*day/L) | | Study Epoch 2, Month 6: Day 0 pre-infusion, and at Days 2, 4, 10, 21 and 28 post-infusion | | | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Area Under the Curve Over the Infusion Interval (AUCTau) | | PKAS included all participants in the Safety Analysis Set who have at least 1 evaluable post-dose concentration data for PK assessments without major protocol deviations or events affecting the PK results. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | g*day/L | | Study Epoch 2, Month 6: Day 0 pre-infusion, and at Days 2, 4, 10, 21 and 28 post-infusion | | | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Apparent Clearance (CL/F) | | PKAS included all participants in the Safety Analysis Set who have at least 1 evaluable post-dose concentration data for PK assessments without major protocol deviations or events affecting the PK results. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliters per day (mL/day) | | Study Epoch 2, Month 6: Day 0 pre-infusion, and at Days 2, 4, 10, 21 and 28 post-infusion | | | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Maximum Concentration (Cmax) | | PKAS included all participants in the Safety Analysis Set who have at least 1 evaluable post-dose concentration data for PK assessments without major protocol deviations or events affecting the PK results. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | g/L | | Study Epoch 2, Month 6: Day 0 pre-infusion, and at Days 2, 4, 10, 21 and 28 post-infusion | | | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Minimum Concentration (Cmin) | | PKAS included all participants in the Safety Analysis Set who have at least 1 evaluable post-dose concentration data for PK assessments without major protocol deviations or events affecting the PK results. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | g/L | | Study Epoch 2, Month 6: Day 0 pre-infusion, and at Days 2, 4, 10, 21 and 28 post-infusion | | | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Time to Maximum Concentration (Tmax) | | PKAS included all participants in the Safety Analysis Set who have at least 1 evaluable post-dose concentration data for PK assessments without major protocol deviations or events affecting the PK results. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Median | Full Range | days | | Study Epoch 2, Month 6: Day 0 pre-infusion, and at Days 2, 4, 10, 21 and 28 post-infusion | | | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Terminal Half-life (T 1/2) | | PKAS included all participants in the Safety Analysis Set who have at least 1 evaluable post-dose concentration data for PK assessments without major protocol deviations or events affecting the PK results. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | days | | Study Epoch 2, Month 6: Day 0 pre-infusion, and at Days 2, 4, 10, 21 and 28 post-infusion | | | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) Excluding Infections, Related and Not Related | An SAE is defined as an untoward medical occurrence that at any dose is fatal, life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. Number of participants who experienced SAEs, related or not related, was reported. | Safety Analysis Set (SAS) included all participants who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | | From first dose of study drug up to EOS (up to 4 years 9 months) | | | | ID | Title | Description |
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| OG000 | Epoch 1 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. | | OG001 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Rate of SAEs Excluding Infections, Related and Not Related, Per Infusion | Rate of SAEs per infusion was calculated as number of serious adverse events/total number of infusions administered to participants in the analysis set. Rate of SAEs per infusion (excluding infections) was reported. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Number | | SAEs per infusion | | From first dose of study drug up to EOS (up to 4 years 9 months) | Infusions | Infusions | | ID | Title | Description |
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| OG000 | Epoch 1 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. | | OG001 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Number of Participants With All Treatment Emergent Adverse Events (TEAEs) Excluding Infections, Related and Not Related | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Number of participants who experienced TEAEs, related or not related, was reported. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | | From first dose of study drug up to EOS (up to 4 years 9 months) | | | | ID | Title | Description |
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| OG000 | Epoch 1 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. | | OG001 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Rate of All TEAEs Excluding Infections, Related and Not Related, Per Infusion | Rate of all TEAEs per infusion was calculated as number of any 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. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Number | | adverse reaction event per infusion | | From first dose of study drug up to EOS (up to 4 years 9 months) | Infusion | Infusion | | ID | Title | Description |
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| OG000 | Epoch 1 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. | | OG001 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Number of Participants With Local TEAEs Excluding Infections, Related and Not Related | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Number of participants who experienced local TEAEs, related or not related, was reported. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | | From first dose of study drug up to EOS (up to 4 years 9 months) | | | | ID | Title | Description |
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| OG000 | Epoch 1 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. | | OG001 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Rate of Local TEAEs Excluding Infections, Related and Not Related, Per Infusion | Rate of local TEAEs per infusion was calculated as number of local TEAEs/total number of infusions administered to participants in the analysis set. Rate of local TEAEs per infusion (excluding infections) was reported. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Number | | local TEAEs per infusion | | From first dose of study drug up to EOS (up to 4 years 9 months) | Infusion | Infusion | | ID | Title | Description |
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| OG000 | Epoch 1 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. | | OG001 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Number of Participants With Systemic TEAEs Excluding Infections, Related and Not Related | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Number of participants who experienced systemic TEAEs, related or not related, was reported. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | | From first dose of study drug up to EOS (up to 4 years 9 months) | | | | ID | Title | Description |
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| OG000 | Epoch 1 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. | | OG001 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Rate of Systemic TEAEs Excluding Infections, Related and Not Related, Per Infusion | Rate of systemic TEAEs per infusion was calculated as number of systemic TEAEs/total number of infusions administered to participants in the analysis set. Rate of systemic TEAEs per infusion (excluding infections) was reported. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Number | | systemic TEAEs per infusion | | From first dose of study drug up to EOS (up to 4 years 9 months) | Infusion | Infusion | | ID | Title | Description |
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| OG000 | Epoch 1 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. | | OG001 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Number of Participants With All Temporally Associated TEAEs Excluding Infections | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Number of participants who experienced all temporally associated TEAEs, related or not related, was reported. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | | From beginning of infusion up to 72 hours post infusion | | | | ID | Title | Description |
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| OG000 | Epoch 1 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. | | OG001 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Rate of All Temporally Associated TEAEs Excluding Infections Per Infusion | Rate of all temporally associated TEAEs per infusion was calculated as number of all temporally associated TEAEs/total number of infusions administered to participants in the analysis set. Rate of all temporally associated TEAEs per infusion (excluding infections) was reported. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Number | | temporally associated TEAEs per infusion | | From beginning of infusion up to 72 hours post infusion | Infusion | Infusion | | ID | Title | Description |
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| OG000 | Epoch 1 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. | | OG001 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Number of Participants With All Related (Causally) and/or Temporally Associated TEAEs Excluding Infections | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. 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. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Count of Participants | | Participants | No | From beginning of infusion up to 72 hours post infusion | | | | ID | Title | Description |
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| OG000 | Epoch 1 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. | | OG001 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Rate of Participants With All Related (Causally) and/or Temporally Associated TEAEs Excluding Infections Per Infusion | 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. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Number | | related temporally TEAEs per infusion | | From beginning of infusion up to 72 hours post infusion | Infusion | Infusion | | ID | Title | Description |
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| OG000 | Epoch 1 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. | | OG001 | Epoch 2 |
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| Secondary | Percentage of Participants With Any TEAEs Excluding Infections | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Percentages are rounded off to whole number at the nearest decimal. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Number | | percentage of participants | | From first dose of study drug up to EOS (up to 4 years 9 months) | | | | ID | Title | Description |
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| OG000 | Epoch 1 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. | | OG001 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Number of Participants Who Developed Positive Titer (≥160) of Binding or Neutralizing Antibodies to rHuPH20 | Number of participants who developed positive titer (rHuPH20 titer ≥160) of binding antibodies to rHuPH20 was reported. Neutralizing antibodies were only tested if the participant had a titer of ≥160 of binding antibodies. Participants with multiple assessments of titer of ≥160 of binding antibodies are counted only once. | FAS included all participants who provided informed consent, and met enrollment eligibility. | Posted | | Count of Participants | | Participants | No | From first dose of study drug up to EOS (up to 4 years 9 months) | | | | ID | Title | Description |
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| OG000 | Epoch 1 + Epoch 2 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Percentage of Participants Who Developed Positive Titer (≥160) of Binding or Neutralizing Antibodies to rHuPH20 | Percentage of participants who developed positive titer (rHuPH20 titer ≥160) of binding antibodies to rHuPH20 was reported. Neutralizing antibodies were only tested if the participant had a titer of ≥160 of binding antibodies. Participants with multiple assessments of titer of ≥160 of binding antibodies are counted only once. Percentages are rounded off to whole number at the nearest decimal. | FAS included all participants who provided informed consent, and met enrollment eligibility. | Posted | | Number | | percentage of participants | | From first dose of study drug up to EOS (up to 4 years 9 months) | | | | ID | Title | Description |
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| OG000 | Epoch 1 + Epoch 2 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Number of Infusions Per Month | | SAS included all participants who received at least one dose of HyQvia. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Median | Full Range | infusions per month | | Study Epoch 2: Up to 36 months | | | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Number of Infusion Sites (Needle Sticks) Per Infusion | | SAS included all participants who received at least one dose of HyQvia. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Mean | Standard Deviation | infusion sites per infusion | | Study Epoch 2: Up to 36 months | Infusion | Infusion | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Number of Infusion Sites (Needle Sticks) Per Month | | SAS included all participants who received at least one dose of HyQvia. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Median | Full Range | infusion sites per month | | Study Epoch 2: Up to 36 months | | | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Duration of Infusion | Duration of infusion is calculated as (stop time of infusion - start time of infusion) (in Epoch 2). Duration of infusion is the time from the start of rHuPH20 infusion until the stop time of immunoglobulin infusion. | SAS included all participants who received at least one dose of HyQvia. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Median | Full Range | minutes (mins) | | Study Epoch 2: Up to 36 months | Infusion | Infusion | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Maximum Infusion Rate Per Site | HYQVIA treatment infusions in Epoch 2 were given at a rate of 10 milliliters per hour per site (mL/h/site) to 160 ml/h/site (body weight [BW] of <40 kg) and 10 mL/h/site to 300 mL/h/site (BW of ≥40 kg). | SAS included all participants who received at least one dose of HyQvia. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Mean | Standard Deviation | milliliters per hour per site(mL/h/site) | | Study Epoch 2: Up to 36 months | Infusion | Infusion | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Infusion Volume Per Site | Infusion volume per site is calculated as (actual IgG volume (mL) / total number of infusion sites used). | SAS included all participants who received at least one dose of HyQvia. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Mean | Standard Deviation | mL/site | | Study Epoch 2: Up to 36 months | Infusion | Infusion | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Infusions Which Were Discontinued, Slowed, or Interrupted Due to an AE | | SAS included all participants who received at least one dose of HyQvia. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Number | | infusions | | Study Epoch 2: Up to 36 months | Infusion | Infusion | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Percentage of Infusions Which Were Discontinued, Slowed, or Interrupted Due to an AE | Percentages are rounded off to whole number at the nearest decimal. | SAS included all participants who received at least one dose of HyQvia. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Number | | percentage of infusions | | Study Epoch 2: Up to 36 months | Infusion | Infusion | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 1: Number of Weeks to Reach Final Dose Interval | | SAS included all participants who received at least one dose of HyQvia. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in SAP, this outcome measure was planned only for Epoch 1. | Posted | | Median | Full Range | weeks | | Epoch 1 (up to 6 weeks) | | | | ID | Title | Description |
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| OG000 | Epoch 1 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. |
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| Secondary | Epoch 2: Percentage of Participants Who Achieved a Treatment Interval of Three or Four Weeks in Epoch 2 | Percentages are rounded off to whole number at the nearest decimal. Percentages may sum up to more than 100% as assigned treatment interval could be changed during the study. | SAS included all participants who received at least one dose of HyQvia. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Number | | percentage of participants | | Study Epoch 2: Up to 36 months | | | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Epoch 2: Percentage of Participants Who Maintained a Treatment Interval of Three or Four Weeks in Epoch 2 for 12 Months | Percentages are rounded off to whole number at the nearest decimal. | SAS included all participants who received at least one dose of HyQvia. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Number | | percentage of participants | | Study Epoch 2: Up to 12 months | | | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Health-related Quality of Life (HRQoL): Change From Baseline in Pediatric Quality of Life Inventory (Peds-QL) Score | Peds-QL=generic questionnaire developed and validated to measure HRQoL among pediatric population. It included assessment of 4 dimensions: physical functioning (8 items), emotional functioning (8 items), social functioning (8 items), and school functioning (Age groups: Toddler (2-4years),Young child (5-7years),Child (8-12years), and Teens (13-<16years). Depending on the participants age, questionnaire may be completed by participant or parent/caregiver as appropriate. Items were scored on a 5-point Likert scale: 0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; and 4=almost always a problem). All Scores were transformed on a total scale from 0-100 where, 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicating better health status. End of Epoch 2 summarizes all participant's data for their last epoch 2 visit (so not including the participant that discontinued in epoch 1). | SAS included all participants who received at least one dose of HyQvia. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at a specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Epoch 1: Baseline (First Infusion); Study Epoch 2: Up to Month 36 | | | | ID | Title | Description |
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| OG000 | Epoch 1 + Epoch 2 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | HRQoL: Change From Baseline in EuroQol Five Dimensions Questionnaire (EQ-5D) Score | The EQ-5D is a validated, self-administered assessment of overall health consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participants were asked to describe their health state that day by choosing 1 of 3 responses that reflect the levels of severity for each of the five dimensions: no problems, some or moderate problems, or extreme problems. The domain scores are calculated with higher scores indicating worsening health status. The EQ-5D also includes a standard vertical 20-cm visual analogue scale (similar to a thermometer) for recording a participant's rating of their current HRQoL state, which ranged from 0 to 100, where 0 indicated worst imaginable health state and 100 was best imaginable health state. End of Epoch 2 summarizes all participant's data for their last epoch 2 visit (so not including the participant that discontinued in epoch 1). | SAS included all participants who received at least one dose of HyQvia. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at a specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Epoch 1: Baseline (First Infusion); Study Epoch 2: Up to Month 36 | | | | ID | Title | Description |
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| OG000 | Epoch 1 + Epoch 2 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Treatment Preference and Satisfaction: Change From Baseline in Assessment of Life Quality Index (LQI) Score | The LQI is a validated questionnaire assessing participant perceptions of their HRQoL and their treatment specifically among participants who use IgG therapy. This questionnaire covers 4 domains: treatment interferences, therapy-related problems, therapy setting, and treatment costs. The LQI domains are scored from 0 to 100, with higher scores associated with better IgG treatment satisfaction. End of Epoch 2 summarizes all participant's data for their last epoch 2 visit (so not including the participant that discontinued in epoch 1). | SAS included all participants who received at least one dose of HyQvia. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at a specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Epoch 1: Baseline (First Infusion); Study Epoch 2: Up to Month 36 | | | | ID | Title | Description |
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| OG000 | Epoch 1 + Epoch 2 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Treatment Preference and Satisfaction: Change From Baseline in Assessment of Treatment Satisfaction and Medication Questionnaire (TSQM-9) Score | The TSQM-9 is a 9-item, validated, self-administered instrument to assess participant satisfaction with medication, which assesses 3 domains: effectiveness, convenience, and global satisfaction. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction. End of Epoch 2 summarizes all participant's data for their last epoch 2 visit (so not including the participant that discontinued in epoch 1). | SAS included all participants who received at least one dose of HyQvia. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at a specified timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Epoch 1: Baseline (First Infusion); Study Epoch 2: Up to Month 36 | | | | ID | Title | Description |
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| OG000 | Epoch 1 + Epoch 2 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Treatment Preference and Satisfaction: Number of Participants Who Completed Treatment Preference Questionnaire | The treatment preference questionnaire, internally developed by the study sponsor, is a self-administered, non-validated scale assessing participant preference for various attributes of immunoglobulin G (IgG) therapy.End of Epoch 2 summarizes all participant's data for their last epoch 2 visit (so not including the participant that discontinued in epoch 1). | SAS included all participants who received at least one dose of HyQvia. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | Posted | | Count of Participants | | Participants | | Study Epoch 2: Up to Month 36 | | | | ID | Title | Description |
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| OG000 | Epoch 2 | Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Health Resource Utilization: Days Not Able to go to School or Work, or to Perform Normal Daily Activities | Days not able to go to school or work, or to perform normal daily activities due to infection or other illnesses were calculated as days not able to go to school or work, or to perform normal daily activities due to infection or other illnesses per participant-year. Per participant-years = number or days reported / total number of years of study duration, i.e., the sum of study duration for all participants in the analysis set, divided by 365.25. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Number | | days per participant-year | | From first dose of study drug up to EOS (up to 4 years 9 months) | Years | Years | | ID | Title | Description |
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| OG000 | Epoch 1 + Epoch 2 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Health Resource Utilization: Days on Antibiotics | Days on antibiotics were calculated as days on antibiotics per participant-year. Per participant-years = number or days reported / total number of years of study duration, i.e., the sum of study duration for all participants in the analysis set, divided by 365.25. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Number | | days per participant-year | | From first dose of study drug up to EOS (up to 4 years 9 months) | Infusion | Infusion | | ID | Title | Description |
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| OG000 | Epoch 1 + Epoch 2 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Health Resource Utilization: Number of Hospitalizations | Number of hospitalizations, indication for the hospitalization (infection or non-infection) were calculated as number of hospitalizations, indication for the hospitalization (infection or non-infection) per participant-year. Per participant-years = number or days reported / total number of years of study duration, i.e., the sum of study duration for all participants in the analysis set, divided by 365.25. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Number | | hospitalizations per participant-year | | From first dose of study drug up to EOS (up to 4 years 9 months) | | | | ID | Title | Description |
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| OG000 | Epoch 1 + Epoch 2 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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| Secondary | Health Resource Utilization: Number of Days Hospitalized Per Participant-Year | Number of days hospitalized were calculated as number of days hospitalized per participant-year. Per participant-years = number or days reported / total number of years of study duration, i.e., the sum of study duration for all participants in the analysis set, divided by 365.25. | SAS included all participants who received at least one dose of HyQvia. | Posted | | Number | | days per participant-year | | From first dose of study drug up to EOS (up to 4 years 9 months) | Participant-Years | Participant-Years | | ID | Title | Description |
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| OG000 | Epoch 1 + Epoch 2 | Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks. Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months. |
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