| Primary | Validated Acute Serious Bacterial Infection (VASBI) Rate | Serious acute bacterial infections include bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess that are caused by a recognized bacterial pathogen. VASBI rate is the mean number of VASBIs per participant per year, recorded for SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only. The mean number of VASBIs per participant per year and the 99% upper confidence limit for the acute serious bacterial infection rate were calculated using a Poisson model to account for the length of the observation periods per participant. | | Posted | | Number | | Estimated infections/year | | Throughout the study period (17 months) | | | | ID | Title | Description |
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| OG000 | Full Analysis Data Set (FADS) | All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| For SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only | Poisson | | <0.0001 | Testing the null hypothesis of 1 VASBI/year against a one-sided alternative at the 0.01 level of statistical significance. | Poisson | 0.025 | | | 1-Sided | 99 | | 0.046 | | | | | Superiority or Other (legacy) | | |
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| Secondary | Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years | Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of ratio of Area Under the Concentration Curve (AUC)/Week after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage. | Participants ≥ 12 years exposed to either or both study drugs with AUC measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Number | 90% Confidence Interval | Percentage | | PK AUC evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion | | | | ID | Title | Description |
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| OG000 | % Ratio IgG AUC/Week of SC/ IV | Percentage Ratio of IgG AUC (/Week) after SC administration with rHuPH20/ IgG AUC (/Week) after IV administration of IGIV, 10% |
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| Secondary | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years | Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of trough levels after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage. | Participants aged 2 to < 12 years exposed to either or both study drugs with available IgG trough level measurements | Posted | | Number | 95% Confidence Interval | Percentage | | IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp-up for SC) and at end of study visit | | | | ID | Title | Description |
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| OG000 | %Ratio IgG Trough Level of SC/IV | Percentage Ratio IgGTrough Level after SC administration with rHuPH20/IgG versus after IV administration of IGIV, 10% for participants aged 2 to < 12 years |
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| Secondary | Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20 | Bioavailability of immunoglobulin (IgG) after subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10%, with and without recombinant human hyaluronidase (rHuPH20) (from current study 160603 and study 160601, respectively), as measured by ratio of AUC of IgG per dose/kg with versus without rHuPH20. Expressed as a percentage. This was analysed for participants in Stratum A , participants in Stratum B and for all participants who received IGIV, 10% via SC administration (Stratum A plus Stratum B): Stratum A: Participants who provided data both on SC with AND without rHuPH20 ie, participants who participated in both studies 160601 and 160603; Stratum B: Participants who provided data on SC with OR without rHuPH20, but not on both (participants who participated in study 160601 OR 160603, but not in both studies). | Participants in the Full Analysis Data Set aged ≥ 12 years from the current study (160603) and prior Baxter study 160601 who received IGIV, 10% via SC administration | Posted | | Number | 90% Confidence Interval | Percentage | | PK: 160603 (IV: before infusion (inf.) #4 [3-week treatment interval] or inf. #3 [4-week treatment interval];SC: before last SC inf.) 1 hour pre-inf. ≤28 days (+/-2 days) post-inf.; 160601- 1 hour pre-inf. (before inf. #8) ≤7 days (+/-1 day) post-inf. | | | | ID | Title | Description |
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| OG000 | Ratio IgG AUC of SC With and Without rHuPH20 | Percentage Ratio of IgG AUC (dose per kg) with and without rHuPH20 for SC administration of IGIV, 10% |
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| Secondary | Annual Rate of All Infections Per Participant | Annual rate of all infections per participant after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the annual rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary endpoint. | | Posted | | Number | 95% Confidence Interval | Estimated infections/year | | Throughout the study period (17 months) | | | | ID | Title | Description |
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| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | |
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| Secondary | Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | Trough levels of immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up | | Posted | | Median | 95% Confidence Interval | g/L | | IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for IV and SC (except during ramp up for SC) and at end of study visit. | | | | ID | Title | Description |
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| OG000 | Participants Aged 2 to <12 Years | | | OG001 | Participants ≥12 Years | |
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| Secondary | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | Trough levels of immunoglobulin (IgG) subclasses after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up by IgG subclasses 1 to 4 at end of IV treatment and end of SC treatment with rHuPH20 IgG subclass 1 (IgG 1) IgG subclass 2 (IgG 2) IgG subclass 3 (IgG 3) IgG subclass 4 (IgG 4) | Participants who have been exposed to either or both study drugs with available IgG subclass trough level measurements | Posted | | Median | 95% Confidence Interval | mg/dL | | IgG subclasses (1-4) trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp up for SC) and at end of study visit | | | | ID | Title | Description |
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| OG000 | Participants Aged 2 to <12 Years | | | OG001 | Participants ≥ 12 Years | |
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| Secondary | Antibody Levels to Tetanus (Clostridium Tetani Toxoid) | Antibody levels to Tetanus (Clostridium tetani toxoid) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20 | Participants in Full Analysis Data Set with available specific antibody test results | Posted | | Median | 95% Confidence Interval | IU/mL | | IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit | | | | ID | Title | Description |
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| OG000 | Participants Aged 2 to <12 Years | | | OG001 | Participants ≥ 12 Years | |
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| Secondary | Antibody Levels to Haemophilus Influenzae | Antibody levels to Haemophilus influenzae after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20 | Participants in Full Analysis Data Set with available specific antibody test results | Posted | | Median | 95% Confidence Interval | μg/mL | | IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit | | | | ID | Title | Description |
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| OG000 | Participants Aged 2 to <12 Years | | | OG001 | Participants ≥ 12 Years | |
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| Secondary | Antibody Levels to Measles | Antibody levels to measles after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20 | Participants in the Full Analysis Data Set with available specific antibody test results | Posted | | Median | 95% Confidence Interval | Titer | | IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit | | | | ID | Title | Description |
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| OG000 | Participants Aged 2 to <12 Years | | | OG001 | Participants ≥ 12 Years | |
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| Secondary | Antibody Levels to Hepatitis B | Antibody levels to hepatitis B after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20 | Participants in the Full Analysis Data Set with available specific antibody test results | Posted | | Median | 95% Confidence Interval | mIU/mL | | IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit | | | | ID | Title | Description |
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| OG000 | Participants Aged 2 to <12 Years | | | OG001 | Participants ≥ 12 Years | |
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| Secondary | IgG Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older | Minimal immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and Older | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | g/L | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion | | | | ID | Title | Description |
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| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
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| Secondary | IgG Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older | Immunoglobulin (IgG) Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval). | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | g*days/L | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
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| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
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| Secondary | IgG Clearance (CL) for Participants Aged 12 Years and Older | Immunoglobulin (IgG) Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20. Clearance and apparent clearance are determined by weight adjusted dose divided by total AUC. | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | mL/kg/day | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
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| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
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| Secondary | IgG Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older | Maximum immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | g/L | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
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| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
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| Secondary | IgG Terminal Half Life (T1/2) for Participants Aged 12 Years and Older | Terminal half life (T1/2) for immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50% during the terminal phase | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | Days | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
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| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
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| Secondary | Time to Maximum IgG Concentration (T-max) for Participants Aged 12 Years and Older | Time to Maximum Immunoglobulin (IgG) Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | Days | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
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| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
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| Secondary | Tetanus Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older | Minimal tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | IU/mL | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
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| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
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| Secondary | Tetanus Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older | Tetanus (clostridium tetani toxoid) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval). | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | IU*days/mL | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
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| Secondary | Tetanus Antibody Clearance (CL) for Participants Aged 12 Years and Older | Tetanus (clostridium tetani toxoid) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20. Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC. | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | nL/IU/day | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
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| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
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| Secondary | Tetanus Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older | Terminal half life (T1/2) for tetanus (clostridium tetani toxoid) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Terminal half life is the time it takes for the plasma concentration or the amount of tetanus antibody in the body to be reduced by 50% during the terminal phase | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | Days | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
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| Secondary | Tetanus Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older | Maximum tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | IU/mL | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
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| Secondary | Time to Maximum Tetanus Antibody Concentration (T-max) for Participants Aged 12 Years and Older | Time to Maximum tetanus (clostridium tetani toxoid) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | Days | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
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| Secondary | H. Influenzae Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older | Minimal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | μg/mL | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
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| Secondary | H. Influenzae Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older | Influenza (haemophilus influenzae) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval). | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | μg*days/mL | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
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| Secondary | H. Influenzae Antibody Clearance (CL) for Participants Aged 12 Years and Older | Influenza (haemophilus influenzae) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20. Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC. | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | L/kg/day | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
| |
| Secondary | H. Influenzae Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older | Maximal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | μg/mL | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
| |
| Secondary | H. Influenzae Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older | Terminal half life (T1/2) for influenza (haemophilus influenzae) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Terminal half life is the time it takes for the plasma concentration or the amount of influenza antibody in the body to be reduced by 50% during the terminal phase. | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | Days | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
| |
| Secondary | Time to Maximum H. Influenzae Antibody Concentration (T-max) for Participants Aged 12 Years and Older | Time to Maximum influenza (haemophilus influenzae) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older | Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28* *Measurements at Day 28 for the 4-week treatment interval only | Posted | | Median | 95% Confidence Interval | Days | | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 | |
| |
| Secondary | Rate of Days Off School or Work | Monthly rate of days off school or work after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month were defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days. | | Posted | | Number | 95% Confidence Interval | Days off per month | | Monthly, for up to 17 months | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Rate of Days on Antibiotics | Monthly rate of days on antibiotics after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month was defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days. | | Posted | | Number | 95% Confidence Interval | Days on antibiotics per month | | Monthly, for up to 17 months | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Rate of Acute Physician Visits | Monthly rate of acute physician visits after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days. | | Posted | | Number | 95% Confidence Interval | Visits per month | | Monthly, for up to 17 months | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Rate of Days in Hospital | Monthly rate of days in hospital after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days. | | Posted | | Number | 95% Confidence Interval | Days per month | | Monthly, for up to 17 months | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | Percentage of participants for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs). An infusion was deemed as tolerated if there are no serious Adverse Drug Reactions (ADR), no non-serious moderate or severe local ADRs that prevent completion of the infusion and no non-serious moderate or severe systemic ADRs during infusion or within 60 minutes of completion of the infusion. | | Posted | | Number | | Percentage of participants | | Throughout the study period (17 months) | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | Percentage of infusions for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs). IV administration of IGIV, 10%: 365 infusions; SC administration of IGIV, 10% with rHuPH20: 1129 infusions | | Posted | | Number | | Percentage of infusions | | Throughout the study period (17 months) | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Rate of Temporally Associated AEs Per Infusion | Rate of all AEs (including and excluding infections) per infusion that began during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of an infusion ("temporally associated") | Safety Analysis Data Set (SADS) | Posted | | Median | 95% Confidence Interval | Number of AEs per infusion | | During infusion or within 72 hours of completion of infusion | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Percentage of Participants Reporting ≥1 Temporally Associated AEs | Percentage of participants reporting at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion ("temporally associated") | | Posted | | Number | | Percentage of participants | | During infusion or within 72 hours of completion of infusion | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Percentage of Infusions Resulting in ≥1 Temporally Associated AEs | Percentage of infusions resulting in at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion ("temporally associated") | | Posted | | Number | | Percentage of infusions | | During infusion or within 72 hours of completion of infusion | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Percentage of participants reporting at least 1 Moderate or Severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion ("temporally associated") | | Posted | | Number | | Percentage of participants | | During infusion or within 72 hours of completion of infusion | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 Including Ramp-up | Includes 2 participants who withdrew during ramp-up SC and rHuPH20 administration of IGIV, 10% |
| |
| Secondary | Percentage of Infusions Resulting in ≥1 Temporally Associated Moderate or Severe AEs Within 72 Hours of Completion of Infusion | Percentage of infusions resulting in at least 1 moderate or severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion ("temporally associated") | | Posted | | Median | 95% Confidence Interval | Percentage of infusions | | During infusion or within 72 hours of completion of infusion | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Percentage of SC Doses of IGIV, 10% and rHuPH20 Tolerated at 1 Infusion Site | Percentage of subcutaneous (SC) doses of immune globulin intravenous (IGIV), 10% and recombinant human hyaluronidase (rHuPH20) tolerated at 1 infusion site. An infusion was deemed as tolerated if there were no serious adverse drug reactions (ADRs), no non-serious moderate or severe local ADRs that prevented completion of the infusion, and no non-serious moderate or severe systemic ADRs during or within 60 minutes of completion of the infusion. | | Posted | | Median | 95% Confidence Interval | Percentage of infusions | | During infusion or within 60 minutes of completion of the infusion | | | | ID | Title | Description |
|---|
| OG000 | SC Administration of IGIV, 10% With rHuPH20 at Ramp-up | At start of SC administration of IGIV, 10% with rHuPH20, the first SC dose was a 1-week dose given for a 1-week interval, then if the 1 week SC infusions were tolerated, each week the interval (and dose) was increased by 1 week, until the treatment interval was the same as the interval for intravenous treatment (3 weeks or 4 weeks) | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Percentage of Infusions Associated With ≥1 Systemic AE During Infusion or Within 72 Hours of Completion of Infusion | Percentage of intravenous (IV) and subcutaneous (SC) infusions associated with ≥1 systemic AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via IV or SC route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion | | Posted | | Median | 95% Confidence Interval | Percentage of infusions | | During infusion or within 72 hours of completion of infusion | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Percentage of Participants With ≥1 Systemic AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion | Percentage of participants with ≥1 systemic AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion | Participants exposed to either or both study drugs | Posted | | Number | | Percentage of participants | | During infusion or within 72 hours of completion of infusion | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Percentage of Infusions Associated With ≥1 Local AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion | Percentage of IV and SC (with recombinant human hyaluronidase [rHuPH20]) infusions associated with ≥1 local AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with rHuPH20 after ramp-up (during infusion) or within 72 hours of completion of infusion | | Posted | | Median | 95% Confidence Interval | Percentage of infusions | | During infusion or within 72 hours of completion of infusion | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study | Percentage of intravenous (IV) and subcutaneous (SC) infusions with recombinant human hyaluronidase (rHuPH20) after ramp-up of immune globulin intravenous (IGIV), 10% associated with ≥1 local AE (including and excluding infections) at any time during the study | | Posted | | Median | 95% Confidence Interval | Percentage of infusions | | At any time during the study | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion | Percentage of participants With ≥1 local AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion | | Posted | | Number | | Percentage of participants | | During infusion or within 72 hours of completion of infusion | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Percentage of Participants With ≥1 Local AE At Any Time During the Study | Percentage of participants With ≥1 local AE (including and excluding infections) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up at any time during the study | | Posted | | Number | | Percentage of participants | | During infusion or within 72 hours of completion of infusion | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Participant | Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous [IGIV], 10% or recombinant human hyaluronidase [rHuPH20]), that occur at any time during the study divided by the total number of participants | | Posted | | Median | 95% Confidence Interval | Number of AEs per participant | | Throughout the study period (17 months) | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 Including Ramp-up | |
| |
| Secondary | Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Infusion | Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous [IGIV], 10% or recombinant human hyaluronidase [rHuPH20]), that occur at any time during the study divided by the total number of infusions | | Posted | | Median | 95% Confidence Interval | Number of AEs per infusion | | Throughout the study period (17 months) | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Frequency of Dose Corrections (If IgG Trough Levels <4.5 g/L) for Each Study Epoch (IV and SC/rHuPH20 Treatment) | Frequency of dose corrections based on immune globulin G (IgG) trough levels <4.5 g/L IgG, if any, for intravenous (IV) (Epoch 1) and subcutaneous with recombinant human hyaluronidase (SC/rHuPH20) after ramp-up (Epoch 2) administration of immune globulin intravenous (IGIV), 10% Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set. | | Posted | | Number | | Percentage of participants | | Throughout the study period (17 months) | | | | ID | Title | Description |
|---|
| OG000 | Study Epoch 1 | Epoch 1 - IV administration of IGIV, 10% | | OG001 | Study Epoch 2 | Epoch 2 - SC administration of IGIV, 10% with rHuPH20 after ramp-up |
| |
| Secondary | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease | | Posted | | Number | | Number of AEs | | Throughout the study period (17 months) | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe | | Posted | | Number | | Number of AEs | | Throughout the study period (17 months) | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Resp.-Respiratory WBC - White blood cells | | Posted | | Number | | Number of AEs | | Throughout the study period (17 months) | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease | | Posted | | Number | | Number of AEs per infusion | | Throughout the study period (17 months) | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe | | Posted | | Number | | Number of AEs per infusion | | Throughout the study period (17 months) | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); ; RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Resp.-Respiratory WBC - White blood cells | | Posted | | Number | | Number of AEs per infusion | | Throughout the study period (17 months) | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease | | Posted | | Number | | Number of AEs per participant | | Throughout the study period (17 months) | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe | | Posted | | Number | | Number of AEs per participant | | Throughout the study period (17 months) | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Resp.-Respiratory WBC - White blood cells | | Posted | | Number | | Number of AEs per participant | | Throughout the study period (17 months) | | | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs | Percentage of Infusions Associated With ≥1 AE Related to immune globulin intravenous (IGIV), 10%, [administered via intravenous (IV) or subcutaneous (SC) route], recombinant human hyaluronidase (rHuPH20) or both. The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed. | | Posted | | Median | 95% Confidence Interval | Percentage of infusions | | Throughout the study period (17 months) | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 With Ramp-up | |
| |
| Secondary | Percentage of Infusions Tolerated With IV and SC Administration at Dose Used in Study Epoch 2 (SC/rHuPH20 Treatment) | Epoch 2: subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10% with recombinant human hyaluronidase (rHuPH20) after ramp-up. Dose used in Epoch 2 (after ramp-up) was 108% of dose used in intravenous (IV) administration of IGIV, 10%. The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed. | | Posted | | Median | 95% Confidence Interval | Percentage of infusions | | Throughout the study period (17 months) | Infusions | Infusions | | ID | Title | Description |
|---|
| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
| |
| Secondary | Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion | Temporally associated defined as during infusion or within 72 hours of completion of infusion. Related defined as determined by investigator to be at least possibly related to study drug (immune globulin intravenous [IGIV], 10% or recombinant human hyaluronidase [rHuPH20]). Expressed as a percentage. | | Posted | | Median | 95% Confidence Interval | Percentage of AE | | Throughout the study period (17 months) | Infusions | Infusions | | ID | Title | Description |
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| OG000 | IV Administration of IGIV, 10% | | | OG001 | SC Administration of IGIV, 10% With rHuPH20 After Ramp-up | |
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| Secondary | Number of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20) | | | Posted | | Number | | Number of participants | | Throughout the study period (17 months) | | | | ID | Title | Description |
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| OG000 | SC Administration of IGIV, 10% With rHuPH20 | |
| | | Title | Denominators | Categories |
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| Secondary | Percentage of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20) | | | Posted | | Number | | Percentage of participants | | Throughout the study period (17 months) | | | | ID | Title | Description |
|---|
| OG000 | SC Administration of IGIV, 10% With rHuPH20 | |
| | | Title | Denominators | Categories |
|---|
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| Secondary | Number of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis | Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis | | Posted | | Number | | Number of participants | | Throughout the study period (17 months) | | | | ID | Title | Description |
|---|
| OG000 | Participants in Safety Data Analysis Set | Participants exposed to either or both study drugs |
| | |
| Secondary | Percentage of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis | Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis | | Posted | | Number | | Percentage of participants | | Throughout the study period (17 months) | | | | ID | Title | Description |
|---|
| OG000 | Participants in Safety Data Analysis Set | Participants exposed to either or both study drugs |
| | |