Gammagard Liquid and rHuPH20 in PID

• Sponsor: Baxalta now part of Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00814320
• Collaborator: (none)
• Enrollment: 89
• Locations: 14
• Arms: 2
• Actual Duration (Months): 22.8
• Patients Per Site: 6.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of the study is to develop a subcutaneous treatment option for participants with Primary Immunodeficiency Diseases (PID) that allows an administration of Immune Globulin Intravenous (Human), 10% at the same frequency as IV administration.

Condition or Disease	Intervention/Treatment	Phase
Primary Immunodeficiency Diseases (PID)	Biological: Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV); Biological: Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy, Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG) Administered Intravenously or Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency Diseases
• Actual Study Start Date: Dec 18, 2008
• Actual Primary Completion Date: Nov 11, 2010
• Actual Study Completion Date: Nov 11, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Efficacy and tolerability of subcutaneous (SC) infusions of immune globulin intravenous (IGIV), 10% with hyaluronidase (rHuPH20) after ramp-up	Biological: Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV); Comprises subjects previously participating in Study 160601, who now only complete Study Epoch 2 (subcutaneous [SC] infusions) as bioavailability/exposure for intravenous (IV) treatment was already obtained in Study 160601. Study Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment (ramp-up).; Other Names: HYQVIA
Experimental: 2 Pharmacokinetics of intravenous (IV) infusions of immune globulin intravenous (IGIV), 10% and efficacy and tolerability of subcutaneous (SC) infusions of immune globulin intravenous (IGIV), 10% with hyaluronidase (rHuPH20) after ramp-up	Biological: Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV); Comprises all other subjects. Study Epoch 1: IV infusion of IGIV, 10% (same dose and frequency as pre-study) to determine pharmacokinetics. Study Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment (ramp-up).

Outcome Measures

Primary Outcome Measures

1. Validated Acute Serious Bacterial Infection (VASBI) Rate [Throughout the study period (17 months)]

   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.

Secondary Outcome Measures

1. Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years [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]

   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.

2. Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years [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]

   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.

3. Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20 [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.]

   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).

4. Annual Rate of All Infections Per Participant [Throughout the study period (17 months)]

   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.

5. Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 [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.]

   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

6. Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 [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]

   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)

7. Antibody Levels to Tetanus (Clostridium Tetani Toxoid) [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]

   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

8. Antibody Levels to Haemophilus Influenzae [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]

   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

9. Antibody Levels to Measles [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]

   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

10. Antibody Levels to Hepatitis B [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]

    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

11. IgG Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older [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]

    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

12. IgG Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older [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.]

    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).

13. IgG Clearance (CL) for Participants Aged 12 Years and Older [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.]

    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.

14. IgG Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older [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.]

    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

15. IgG Terminal Half Life (T1/2) for Participants Aged 12 Years and Older [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.]

    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

16. Time to Maximum IgG Concentration (T-max) for Participants Aged 12 Years and Older [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.]

    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

17. Tetanus Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older [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.]

    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

18. Tetanus Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older [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.]

    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).

19. Tetanus Antibody Clearance (CL) for Participants Aged 12 Years and Older [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.]

    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.

20. Tetanus Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older [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.]

    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

21. Tetanus Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older [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.]

    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

22. Time to Maximum Tetanus Antibody Concentration (T-max) for Participants Aged 12 Years and Older [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.]

    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

23. H. Influenzae Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older [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.]

    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

24. H. Influenzae Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older [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.]

    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).

25. H. Influenzae Antibody Clearance (CL) for Participants Aged 12 Years and Older [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.]

    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.

26. H. Influenzae Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older [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.]

    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

27. H. Influenzae Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older [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.]

    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.

28. Time to Maximum H. Influenzae Antibody Concentration (T-max) for Participants Aged 12 Years and Older [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.]

    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

29. Rate of Days Off School or Work [Monthly, for up to 17 months]

    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.

30. Rate of Days on Antibiotics [Monthly, for up to 17 months]

    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.

31. Rate of Acute Physician Visits [Monthly, for up to 17 months]

    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.

32. Rate of Days in Hospital [Monthly, for up to 17 months]

    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.

33. 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) [Throughout the study period (17 months)]

    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.

34. 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) [Throughout the study period (17 months)]

    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

35. Rate of Temporally Associated AEs Per Infusion [During infusion or within 72 hours of completion of 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")

36. Percentage of Participants Reporting ≥1 Temporally Associated AEs [During infusion or within 72 hours of completion of infusion]

    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")

37. Percentage of Infusions Resulting in ≥1 Temporally Associated AEs [During infusion or within 72 hours of completion of infusion]

    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")

38. Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs [During infusion or within 72 hours of completion of infusion]

    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")

39. Percentage of Infusions Resulting in ≥1 Temporally Associated Moderate or Severe AEs Within 72 Hours of Completion of Infusion [During infusion or 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")

40. Percentage of SC Doses of IGIV, 10% and rHuPH20 Tolerated at 1 Infusion Site [During infusion or within 60 minutes of completion of the infusion]

    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.

41. Percentage of Infusions Associated With ≥1 Systemic AE During Infusion or Within 72 Hours of Completion of Infusion [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

42. Percentage of Participants With ≥1 Systemic AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion [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

43. Percentage of Infusions Associated With ≥1 Local AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion [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

44. Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study [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

45. Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion [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

46. Percentage of Participants With ≥1 Local AE At Any Time During the Study [During infusion or within 72 hours of completion of infusion]

    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

47. Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Participant [Throughout the study period (17 months)]

    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

48. Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Infusion [Throughout the study period (17 months)]

    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

49. Frequency of Dose Corrections (If IgG Trough Levels <4.5 g/L) for Each Study Epoch (IV and SC/rHuPH20 Treatment) [Throughout the study period (17 months)]

    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.

50. Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) [Throughout the study period (17 months)]

    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

51. Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) [Throughout the study period (17 months)]

    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

52. Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) [Throughout the study period (17 months)]

    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

53. Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) [Throughout the study period (17 months)]

    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

54. Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) [Throughout the study period (17 months)]

    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

55. Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) [Throughout the study period (17 months)]

    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

56. Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) [Throughout the study period (17 months)]

    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

57. Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) [Throughout the study period (17 months)]

    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

58. Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) [Throughout the study period (17 months)]

    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

59. Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs [Throughout the study period (17 months)]

    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.

60. Percentage of Infusions Tolerated With IV and SC Administration at Dose Used in Study Epoch 2 (SC/rHuPH20 Treatment) [Throughout the study period (17 months)]

    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.

61. Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion [Throughout the study period (17 months)]

    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.

62. Number of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20) [Throughout the study period (17 months)]

63. Percentage of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20) [Throughout the study period (17 months)]

64. Number of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis [Throughout the study period (17 months)]

    Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis

65. Percentage of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis [Throughout the study period (17 months)]

    Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participant is 2 years or older at the time of screening

• Written informed consent obtained from either the participant or the participant's legally acceptable representative prior to any study-related procedures and study product administration

• Participant has been diagnosed with a PID disorder requiring antibody replacement as defined by WHO criteria

• Participant has completed or is about to complete Baxter Clinical Study Protocol No. 160601 or has been receiving a regular IGIV-treatment at mean intervals of 21 ± 3 days or 28 ± 3 days, or SC at mean intervals of 5 to 16 days, over a period of at least 3 months prior to enrollment at a minimum dose of 300 mg/kg BW/4 weeks

• Participant has a serum trough level of IgG > 4.5 g/L at the last documented determination

• If female of childbearing potential, participant presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study

• Participant is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

• Participant has a known history of or is positive at enrollment or screening for one or more of the following: Hepatitis B surface antigen (HbsAg), polymerase chain reaction (PCR) for Hepatitis C Virus (HCV), PCR for Human immunodeficiency virus (HIV) Type 1/2

• Participant has levels of alanine aminotransferase (ALT) or aspartate amino transferase (AST) > 2.5 times the upper limit of normal for the testing laboratory

• Participant has persistent severe neutropenia (defined as an absolute neutrophil count [ANC] <= 500/mm3)

• Participant has creatinine clearance (CLcr) values, calculated according to the formula below, which are < 60% of normal for age and gender for males: CLcr = [(140 -

Age(years)) * (body weight (kg))] / [72 * (serum creatinine (mg/dL))] for females:

CLcr = [(140 - Age(years)) * (body weight(kg)) * 0.85] / [72 * (serum creatinine (mg/dL))]

• Participant has been diagnosed with, or has a malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within the last 12 months prior to enrollment; participants treated with immunosuppressive chemotherapeutic agents during this period are excluded

• Participant has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within the last 12 months

• Participant has abnormal protein loss (protein losing enteropathy, nephrotic syndrome)

• Participant has anemia that would preclude phlebotomy for laboratory studies

• Participant has received any blood or blood product other than an IGIV, SC immunoglobulin, immune serum globulin (ISG) preparation, or albumin within the 6 months prior to enrollment

• Participant has an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SC immunoglobulin, and/or ISG infusions

• Participant has immunoglobulin A (IgA) deficiency and known anti IgA antibodies

• Participant is on preventative (prophylactic) antibiotics and cannot stop antibiotics at the time of enrollment

• Participant has active infection who started on antibiotic therapy for the treatment of infection within 7 days prior to screening

• Participant has a bleeding disorder or is on anti-coagulation therapy that results in a platelet count less than 20,000/μL or International Normalized Ration (INR) > 2X control, or who, in the opinion of the investigator would be at significant risk of increased bleeding or bruising as a result of SC therapy

• Participant has total protein > 9 g/dL and participants with myeloma, macroglobulinemia (IgM) and paraproteinemia

• Participant has a known allergy to hyaluronidase

• If female, participant is pregnant or lactating at the time of study enrollment

• Participant has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or device during the course of this study; exception: Baxter Study No. 160601

• Severe dermatitis that would preclude adequate sites for safe product administration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Cypress	California	United States
2		Irvine	California	United States
3		Los Angeles	California	United States
4		San Francisco	California	United States
5		Centennial	Colorado	United States
6		North Palm Beach	Florida	United States
7		Atlanta	Georgia	United States
8		Hinsdale	Illinois	United States
9		Omaha	Nebraska	United States
10		Bronx	New York	United States
11		Dallas	Texas	United States
12		Galveston	Texas	United States
13		Milwaukee	Wisconsin	United States
14		Vancouver	British Columbia	Canada

Sponsors and Collaborators

• Baxalta now part of Shire

Investigators

• Study Director: Study Director, Shire

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Baxalta now part of Shire
• ClinicalTrials.gov Identifier: NCT00814320
• Other Study ID Numbers: 160603
• First Posted: Dec 24, 2008
• Last Update Posted: May 19, 2021
• Last Verified: Apr 1, 2021

• Additional relevant MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G

Study Results

Participant Flow

Recruitment Details	Recruitment was conducted 14 clinical sites in the United States and 1 clinical site in Canada.
Pre-assignment Detail	89 participants who enrolled were screened. Of these, 2 withdrew before treatment (both were screen failures)

Arm/Group Title	2 to <12 Years	12 Years and Older
Arm/Group Description	The same as the other study arm/group (please see "12 Years and Older", due to character limitation) with the exception of the pharmacokinetic assessment that was done. For participants aged 2 to <12 years, immunoglobulin G (IgG) trough levels only were assessed in order to avoid multiple blood drawings in small children.	EPOCH 1: Pharmacokinetics (PK) of intravenous (IV) administration of immune globulin intravenous (IGIV), 10%. Participants who previously participated in Study 160601 entered this study directly to Epoch 2 ramp-up. PK data collected during IV treatment in Study 160601 was compared with PK data from subcutaneous (SC) treatment during this study. EPOCH 2 RAMP-UP ("ramp-up"):Treatment intervals/ doses used for initial SC infusions of IGIV, 10% were slowly increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC. Prior to SC infusions, recombinant human hyaluronidase (rHuPH20) was administered at a minimum dose of 75 U/g IgG. EPOCH 2 after RAMP-UP: Participants were treated SC with IGIV, 10% with rHuPH20 at 108% of IV dose from Epoch 1 (or from study 160601). Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG. Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV.
Period Title: Epoch 1 (IV Treatment)
STARTED	14	73
COMPLETED	13	71
NOT COMPLETED	1	2
Period Title: Epoch 1 (IV Treatment)
STARTED	13	71
COMPLETED	13	70
NOT COMPLETED	0	1
Period Title: Epoch 1 (IV Treatment)
STARTED	13	70
COMPLETED	11	70
NOT COMPLETED	2	0
Period Title: Epoch 1 (IV Treatment)
STARTED	11	70
COMPLETED	8	60
NOT COMPLETED	3	10

Baseline Characteristics

Arm/Group Title	2 to <12 Years	12 Years and Older	Total
Arm/Group Description	The same as the other study arm/group (please see "12 Years and Older", due to character limitation) with the exception of the pharmacokinetic assessment that was done. For participants aged 2 to <12 years, immunoglobulin G (IgG) trough levels only were assessed in order to avoid multiple blood drawings in small children.	EPOCH 1: Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of Subcutaneous (SC) infusions Recombinant human hyaluronidase (rHuPH20) + immune globulin intravenous (IGIV). Participants who previously participated in Study 160601 entered this study at Epoch 2. PK data collected during IV treatment in Study 160601 were used for comparison with PK data from SC treatment during this study (160603). EPOCH 2: (ramp-up and After ramp-up). Participants were treated SC with GAMMAGARD LIQUID/KIOVIG at 108% of IV dose from Epoch 1 or Study 160601. 108% was derived from PK data from Study 160602. Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG. Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment (ramp-up), to allow participants to adjust to increasing volume administered SC. Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV.	Total of all reporting groups
Overall Participants	14	73	87
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	8.0	44.0	35.0
Sex: Female, Male (Count of Participants)
Female	6 42.9%	37 50.7%	43 49.4%
Male	8 57.1%	36 49.3%	44 50.6%
Region of Enrollment (Count of Participants)
United States	14 100%	72 98.6%	86 98.9%
Canada	0 0%	1 1.4%	1 1.1%

Outcome Measures

1. Primary Outcome

Title	Validated Acute Serious Bacterial Infection (VASBI) Rate
Description	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.
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full Analysis Data Set (FADS)
Arm/Group Description	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.
Measure Participants	81
Number [Estimated infections/year]	0.025

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Full Analysis Data Set (FADS)
	Comments	For SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Testing the null hypothesis of 1 VASBI/year against a one-sided alternative at the 0.01 level of statistical significance.
	Method	Poisson
	Comments
Method of Estimation	Estimation Parameter	Poisson
	Estimated Value	0.025
	Confidence Interval	(1-Sided) 99%; to 0.046
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	% Ratio IgG AUC/Week of SC/ IV
Arm/Group Description	Percentage Ratio of IgG AUC (/Week) after SC administration with rHuPH20/ IgG AUC (/Week) after IV administration of IGIV, 10%
Measure Participants	58
Number (90% Confidence Interval) [Percentage]	93.3

3. Secondary Outcome

Title	Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

Participants aged 2 to < 12 years exposed to either or both study drugs with available IgG trough level measurements

Arm/Group Title	%Ratio IgG Trough Level of SC/IV
Arm/Group Description	Percentage Ratio IgGTrough Level after SC administration with rHuPH20/IgG versus after IV administration of IGIV, 10% for participants aged 2 to < 12 years
Measure Participants	11
Number (95% Confidence Interval) [Percentage]	103.8

4. Secondary Outcome

Title	Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20
Description	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).
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ratio IgG AUC of SC With and Without rHuPH20
Arm/Group Description	Percentage Ratio of IgG AUC (dose per kg) with and without rHuPH20 for SC administration of IGIV, 10%
Measure Participants	73
Participants in Stratum A (N=19)	118.7
Participants in Stratum B (N=54)	133.6
Total Participants (N=73)	120.4

5. Secondary Outcome

Title	Annual Rate of All Infections Per Participant
Description	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.
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Full Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	81	81
Number (95% Confidence Interval) [Estimated infections/year]	4.51	2.97

6. Secondary Outcome

Title	Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20
Description	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
Time Frame	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.

Outcome Measure Data

Analysis Population Description

Full Analysis Data Set

Arm/Group Title	Participants Aged 2 to <12 Years	Participants ≥12 Years
Arm/Group Description
Measure Participants	11	70
end of IV part	9.63	10.40
end of SC with rHuPH20 part	9.95	10.70

7. Secondary Outcome

Title	Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20
Description	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)
Time Frame	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

Outcome Measure Data

Analysis Population Description

Participants who have been exposed to either or both study drugs with available IgG subclass trough level measurements

Arm/Group Title	Participants Aged 2 to <12 Years	Participants ≥ 12 Years
Arm/Group Description
Measure Participants	11	70
IgG 1 end of IV treatment (N=11,69)	490.0	574.0
IgG 1 end of SC/rHuPH20 treatment (N=11,70)	455.0	548.0
IgG 2 end of IV treatment (N=11,69)	327.0	360.0
IgG 2 end of SC/rHuPH20 treatment (N=11,70)	315.0	339.0
IgG 3 end of IV treatment (N=11,69)	35.0	32.0
IgG 3 end of SC/rHuPH20 treatment (N=11,70)	49.0	36.0
IgG 4 end of IV treatment (N=11,69)	24.0	14.0
IgG 4 end of SC/rHuPH20 treatment (N=11,70)	23.0	15.0

8. Secondary Outcome

Title	Antibody Levels to Tetanus (Clostridium Tetani Toxoid)
Description	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
Time Frame	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

Outcome Measure Data

Analysis Population Description

Participants in Full Analysis Data Set with available specific antibody test results

Arm/Group Title	Participants Aged 2 to <12 Years	Participants ≥ 12 Years
Arm/Group Description
Measure Participants	10	70
End of IV treatment (N=7,25)	2.230	2.320
End of SC/rHuPH20 treatment (N=10,70)	2.580	2.525

9. Secondary Outcome

Title	Antibody Levels to Haemophilus Influenzae
Description	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
Time Frame	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

Outcome Measure Data

Analysis Population Description

Participants in Full Analysis Data Set with available specific antibody test results

Arm/Group Title	Participants Aged 2 to <12 Years	Participants ≥ 12 Years
Arm/Group Description
Measure Participants	10	70
Influenza antibody end of IV treatment (N=7,24)	2.11	2.36
Influenza antibody end of SC treatment (N=10,70)	1.97	2.58

10. Secondary Outcome

Title	Antibody Levels to Measles
Description	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
Time Frame	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

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Data Set with available specific antibody test results

Arm/Group Title	Participants Aged 2 to <12 Years	Participants ≥ 12 Years
Arm/Group Description
Measure Participants	10	70
Measles antibody end of IV treatment (N=0,1)	NA	64.0
Measles antibody end of SC treatment (N=10,70)	768.0	1024.0

11. Secondary Outcome

Title	Antibody Levels to Hepatitis B
Description	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
Time Frame	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

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Data Set with available specific antibody test results

Arm/Group Title	Participants Aged 2 to <12 Years	Participants ≥ 12 Years
Arm/Group Description
Measure Participants	10	70
Hepatitis B antibody end IV treatment (N=6,25)	212.9	222.8
Hepatitis B antibody end of SC treatment (N=10,70)	242.2	249.2

12. Secondary Outcome

Title	IgG Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older
Description	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
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	68	60
Median (95% Confidence Interval) [g/L]	10.1	10.4

13. Secondary Outcome

Title	IgG Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older
Description	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).
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	68	60
Median (95% Confidence Interval) [g*days/L]	93.9	90.5

14. Secondary Outcome

Title	IgG Clearance (CL) for Participants Aged 12 Years and Older
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	68	60
Median (95% Confidence Interval) [mL/kg/day]	1.4	1.6

15. Secondary Outcome

Title	IgG Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older
Description	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
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	68	60
Median (95% Confidence Interval) [g/L]	21.9	15.5

16. Secondary Outcome

Title	IgG Terminal Half Life (T1/2) for Participants Aged 12 Years and Older
Description	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
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	68	60
Median (95% Confidence Interval) [Days]	35.7	45.3

17. Secondary Outcome

Title	Time to Maximum IgG Concentration (T-max) for Participants Aged 12 Years and Older
Description	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
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	68	60
Median (95% Confidence Interval) [Days]	0.1	5.0

18. Secondary Outcome

Title	Tetanus Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older
Description	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
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	46	60
Median (95% Confidence Interval) [IU/mL]	2.3	2.1

19. Secondary Outcome

Title	Tetanus Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older
Description	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).
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	46	60
Median (95% Confidence Interval) [IU*days/mL]	28.0	22.6

20. Secondary Outcome

Title	Tetanus Antibody Clearance (CL) for Participants Aged 12 Years and Older
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	46	60
Median (95% Confidence Interval) [nL/IU/day]	4.5	5.8

21. Secondary Outcome

Title	Tetanus Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older
Description	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
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	44	50
Median (95% Confidence Interval) [Days]	22.7	30.4

22. Secondary Outcome

Title	Tetanus Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older
Description	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
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	46	60
Median (95% Confidence Interval) [IU/mL]	7.3	5.0

23. Secondary Outcome

Title	Time to Maximum Tetanus Antibody Concentration (T-max) for Participants Aged 12 Years and Older
Description	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
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	46	60
Median (95% Confidence Interval) [Days]	0.1	5.1

24. Secondary Outcome

Title	H. Influenzae Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older
Description	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
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	46	60
Median (95% Confidence Interval) [μg/mL]	2.1	2.2

25. Secondary Outcome

Title	H. Influenzae Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older
Description	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).
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	46	60
Median (95% Confidence Interval) [μg*days/mL]	22.4	22.5

26. Secondary Outcome

Title	H. Influenzae Antibody Clearance (CL) for Participants Aged 12 Years and Older
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	46	60
Median (95% Confidence Interval) [L/kg/day]	5.8	6.4

27. Secondary Outcome

Title	H. Influenzae Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older
Description	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
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	46	60
Median (95% Confidence Interval) [μg/mL]	5.5	4.1

28. Secondary Outcome

Title	H. Influenzae Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	45	55
Median (95% Confidence Interval) [Days]	33.8	35.0

29. Secondary Outcome

Title	Time to Maximum H. Influenzae Antibody Concentration (T-max) for Participants Aged 12 Years and Older
Description	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
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	46	60
Median (95% Confidence Interval) [Days]	0.1	4.8

30. Secondary Outcome

Title	Rate of Days Off School or Work
Description	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.
Time Frame	Monthly, for up to 17 months

Outcome Measure Data

Analysis Population Description

Full Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	81	81
Number (95% Confidence Interval) [Days off per month]	0.23	0.28

31. Secondary Outcome

Title	Rate of Days on Antibiotics
Description	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.
Time Frame	Monthly, for up to 17 months

Outcome Measure Data

Analysis Population Description

Full Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	81	81
Number (95% Confidence Interval) [Days on antibiotics per month]	3.15	1.69

32. Secondary Outcome

Title	Rate of Acute Physician Visits
Description	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.
Time Frame	Monthly, for up to 17 months

Outcome Measure Data

Analysis Population Description

Full Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	81	81
Number (95% Confidence Interval) [Visits per month]	0.33	0.40

33. Secondary Outcome

Title	Rate of Days in Hospital
Description	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.
Time Frame	Monthly, for up to 17 months

Outcome Measure Data

Analysis Population Description

Full Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	81	81
Number (95% Confidence Interval) [Days per month]	0.06	0.02

34. Secondary Outcome

Title	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)
Description	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.
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
% participants with reduced infusion rate only	6.9 49.3%	9.9 13.6%
% participants with interrupted infusion rate only	4.6 32.9%	4.9 6.7%
% participants with infusion stopped only	0.0 0%	1.2 1.6%
% participants with no changes to infusion rate	88.5 632.1%	84.0 115.1%

35. Secondary Outcome

Title	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)
Description	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
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Measure Infusions	365	1129
% infusions with infusion rate reduced only	2.7	1.7
% infusions with interrupted infusion rate only	1.4	0.4
% infusions with infusion stopped only	0.0	0.2
% infusions with no changes to infusion rate	95.9	97.7

36. Secondary Outcome

Title	Rate of Temporally Associated AEs Per Infusion
Description	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")
Time Frame	During infusion or within 72 hours of completion of infusion

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set (SADS)

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Measure Infusions	365	1129
Including infections	0.25	0.21
Excluding infections	0.25	0.17

37. Secondary Outcome

Title	Percentage of Participants Reporting ≥1 Temporally Associated AEs
Description	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")
Time Frame	During infusion or within 72 hours of completion of infusion

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Including infections	66.7 476.4%	86.4 118.4%
Excluding infections	63.2 451.4%	82.7 113.3%

38. Secondary Outcome

Title	Percentage of Infusions Resulting in ≥1 Temporally Associated AEs
Description	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")
Time Frame	During infusion or within 72 hours of completion of infusion

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Measure Infusions	365	1129
Including infections	30.1	24.5
Excluding infections	28.8	22.8

39. Secondary Outcome

Title	Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs
Description	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")
Time Frame	During infusion or within 72 hours of completion of infusion

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 Including Ramp-up
Arm/Group Description	Includes 2 participants who withdrew during ramp-up SC and rHuPH20 administration of IGIV, 10%
Measure Participants	87	83
Including infections	36.8 262.9%	54.3 74.4%
Excluding infections	34.5 246.4%	46.9 64.2%

40. Secondary Outcome

Title	Percentage of Infusions Resulting in ≥1 Temporally Associated Moderate or Severe AEs Within 72 Hours of Completion of Infusion
Description	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")
Time Frame	During infusion or within 72 hours of completion of infusion

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Measure Infusions	365	1129
Including infections	0.0	5.9
Excluding infections	0.0	0.0

41. Secondary Outcome

Title	Percentage of SC Doses of IGIV, 10% and rHuPH20 Tolerated at 1 Infusion Site
Description	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.
Time Frame	During infusion or within 60 minutes of completion of the infusion

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	SC Administration of IGIV, 10% With rHuPH20 at Ramp-up	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description	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)
Measure Participants	83	81
Median (95% Confidence Interval) [Percentage of infusions]	100.0	100.0

42. Secondary Outcome

Title	Percentage of Infusions Associated With ≥1 Systemic AE During Infusion or Within 72 Hours of Completion of Infusion
Description	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
Time Frame	During infusion or within 72 hours of completion of infusion

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Measure Infusions	365	1129
Including infections	25.0	8.3
Excluding infections	25.0	8.3

43. Secondary Outcome

Title	Percentage of Participants With ≥1 Systemic AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion
Description	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
Time Frame	During infusion or within 72 hours of completion of infusion

Outcome Measure Data

Analysis Population Description

Participants exposed to either or both study drugs

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Including infections	64.4 460%	75.3 103.2%
Excluding infections	60.9 435%	67.9 93%

44. Secondary Outcome

Title	Percentage of Infusions Associated With ≥1 Local AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion
Description	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
Time Frame	During infusion or within 72 hours of completion of infusion

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Measure Infusions	365	1129
Including infections	0.0	5.9
Excluding infections	0.0	5.9

45. Secondary Outcome

Title	Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study
Description	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
Time Frame	At any time during the study

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Measure Infusions	365	1129
Including infections	0.0	5.9
Excluding infections	0.0	5.9

46. Secondary Outcome

Title	Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion
Description	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
Time Frame	During infusion or within 72 hours of completion of infusion

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Including infections	4.6 32.9%	51.9 71.1%
Excluding infections	4.6 32.9%	51.9 71.1%

47. Secondary Outcome

Title	Percentage of Participants With ≥1 Local AE At Any Time During the Study
Description	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
Time Frame	During infusion or within 72 hours of completion of infusion

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Including infections	5.7 40.7%	53.1 72.7%
Excluding infections	5.7 40.7%	53.1 72.7%

48. Secondary Outcome

Title	Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Participant
Description	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
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 Including Ramp-up
Arm/Group Description
Measure Participants	87	81
Including infections	0.00	0.09
Excluding infections	0.00	0.09

49. Secondary Outcome

Title	Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Infusion
Description	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
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Measure Infusions	365	1129
Including infections	0.25	0.22
Excluding infections	0.25	0.18

50. Secondary Outcome

Title	Frequency of Dose Corrections (If IgG Trough Levels <4.5 g/L) for Each Study Epoch (IV and SC/rHuPH20 Treatment)
Description	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.
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	Study Epoch 1	Study Epoch 2
Arm/Group Description	Epoch 1 - IV administration of IGIV, 10%	Epoch 2 - SC administration of IGIV, 10% with rHuPH20 after ramp-up
Measure Participants	87	81
Number [Percentage of participants]	0.0 0%	0.0 0%

51. Secondary Outcome

Title	Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F)
Description	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
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Abdominal Discomfort-non-SAE, NR, Mod	0	1
Abdominal Distension-non-SAE, Rboth, Mild	0	1
Abdominal Hernia-non-SAE, NR, Mild	0	1
Abdominal Pain-non-SAE, NR, Mild	1	2
Abdominal Pain-non-SAE, NR, Mod	0	1
Abdominal Pain-non-SAE, Rboth, Mild	0	3
Abdominal Pain-non-SAE, Rboth, Mod	0	1
Abdominal Pain Lower-non-SAE, NR, Mild	0	1
Abdominal Pain Upper-non-SAE, NR, Mild	1	5
Abdominal Pain Upper-non-SAE, NR, Mod	1	0
Abdominal Pain Upper-non-SAE, RIGIV, Mild	0	1
Abdominal Pain Upper-non-SAE, RIGIV, Mod	1	0
Abdominal Pain Upper-non-SAE, Rboth, Mild	0	2
Abdominal Tenderness-non-SAE, NR, Mod	1	0
Abdominal Tenderness-non-SAE, RIGIV, Mild	0	1
Abdominal Tenderness-non-SAE, RIGIV, Mod	0	2
Acarodermatitis-non-SAE, NR, Mild	0	1
Acne-non-SAE, NR, Mild	1	1
Acute Sinusitis-non-SAE, NR, Mild	1	0
Acute Sinusitis-non-SAE, NR, Mod	0	4
Adenoidal Hypertrophy-non-SAE, NR, Mod	0	1
Adnexa Uteri Cyst-non-SAE, NR, Mild	1	0
Adrenocortical Insufficiency Acute-SAE, NR, Mod	0	1
Allergic Respiratory Symptom-non-SAE, NR, Mild	0	1
Allergic Sinusitis-non-SAE, NR, Mild	1	0
Alopecia-non-SAE, NR, Mild	1	0
Animal Bite-non-SAE, NR, Mod	1	0
Antibody Test Positive-non-SAE, Rboth, Mod	0	1
Anxiety-non-SAE, NR, Mild	0	1
Anxiety-non-SAE, NR, Mod	1	0
Aphthous Stomatitis-non-SAE, NR, Mild	2	1
Aphthous Stomatitis-non-SAE, NR, Mod	0	1
Arteriosclerosis Coronary Artery-non-SAE, NR, Mild	0	1
Arthralgia-non-SAE, NR, Mild	0	5
Arthralgia-non-SAE, NR, Mod	1	6
Arthralgia-non-SAE, RIGIV, Mild	0	1
Arthralgia-non-SAE, RIGIV, Mod	0	2
Arthritis-non-SAE, NR, Mod	1	1
Arthropathy-non-SAE, NR, Mod	1	0
Arthropod Bite-non-SAE, NR, Mild	2	2
Arthropod Sting-non-SAE, NR, Mild	0	1
Arthropod Sting-non-SAE, NR, Mod	1	0
Aspiration-non-SAE, NR, Mild	0	1
Asthenia-non-SAE, NR, Mild	0	3
Asthenia-non-SAE, NR, Mod	1	0
Asthenia-non-SAE, RIGIV, Mild	0	1
Asthma-non-SAE, NR, Mild	0	4
Asthma-non-SAE, NR, Mod	8	21
Asthma-non-SAE, NR, Severe	0	1
ADHD-non-SAE, NR, Mod	0	1
Back Injury-non-SAE, NR, Mod	1	0
Back Injury-SAE, NR, Severe	0	1
Back Pain-non-SAE, NR, Mild	1	2
Back Pain-non-SAE, NR, Mod	1	5
Bacterial Prostatitis-non-SAE, NR, Mild	0	1
Blepharitis-non-SAE, NR, Mod	1	0
Blister-non-SAE, NR, Mild	0	1
Blood Pressure Decreased-non-SAE, NR, Mild	0	1
Blood Pressure Decreased-non-SAE, Rboth, Mild	0	1
Blood Pressure Increased-non-SAE, NR, Mod	0	1
Blood Pressure Increased-non-SAE, RIGIV, Mild	0	1
Blood Pressure Increased-non-SAE, RIGIV, Mod	0	1
Blood Pressure Increased-non-SAE, RrHu, Mild	0	1
BP Systolic Increased-non-SAE, RIGIV, Mild	1	0
Blood Urea Increased-non-SAE, NR, Mild	0	1
Body Fat Disorder-non-SAE, NR, Mild	0	1
Body Tinea-non-SAE, NR, Mild	1	0
Body Tinea-non-SAE, NR, Mod	0	1
Bone Pain-non-SAE, NR, Mild	0	1
Breast Pain-non-SAE, NR, Mild	1	0
Bronchal Hyperreactivity-non-SAE, NR, Mild	0	1
Bronchitis-non-SAE, NR, Mild	4	2
Bronchitis-non-SAE, NR, Mod	2	8
Bronchitis-SAE, NR, Mod	1	0
Bronchospasm-non-SAE, NR, Mod	0	1
Burn Infection-non-SAE, NR, Mild	0	1
Burning Sensation-non-SAE, RIGIV, Mild	0	1
Burning Sensation-non-SAE, RIGIV, Mod	0	1
Burning Sensation-non-SAE, RrHu, Mild	0	1
Bursitis-non-SAE, NR, Mild	1	0
Bursitis-non-SAE, NR, Mod	0	1
Candidiasis-non-SAE, NR, Mild	1	0
Candidiasis-non-SAE, NR, Mod	1	1
Cardiac Murmur-non-SAE, NR, Mild	0	1
Cellulitis-non-SAE, NR, Mild	0	1
Cellulitis-non-SAE, NR, Mod	0	3
Cellulitis-non-SAE, Rboth, Mod	0	1
Cerumen Impaction-non-SAE, NR, Mild	0	2
Cervical Dysplasia-SAE, NR, Mild	1	1
Cheilitis-non-SAE, NR, Mild	2	0
Chest Pain-non-SAE, NR, Mild	0	2
Chills-non-SAE, NR, Mild	0	3
Chills-non-SAE, RIGIV, Mild	6	1
Chills-non-SAE, RIGIV, Mod	3	0
Chills-non-SAE, Rboth, Mild	0	1
COPD-non-SAE, NR, Mod	0	2
COPD-non-SAE, NR, Severe	1	0
Chronic Sinusitis-non-SAE, NR, Mild	0	4
Chronic Sinusitis-non-SAE, NR, Mod	1	1
Concussion-non-SAE, NR, Mod	1	0
Confusional State-non-SAE, NR, Mod	0	1
Confusional State-non-SAE, RIGIV, Mild	1	0
Conjunctivitis-non-SAE, NR, Mild	1	2
Conjunctivitis Allergic-non-SAE, NR, Mild	1	0
Conjunctivitis Allergic-non-SAE, NR, Mod	1	0
Conjunctivitis Bacterial-non-SAE, NR, Mild	1	1
Conjunctivitis Bacterial-non-SAE, NR, Mod	0	1
Conjunctivitis Bacterial-non-SAE, NR, Severe	0	1
Constipation-non-SAE, NR, Mild	0	3
Contusion-non-SAE, NR, Mild	1	5
Contusion-non-SAE, NR, Mod	1	0
Contusion-non-SAE, RIGIV, Mod	0	1
Coombs Test Positive-non-SAE, RIGIV, Mild	0	1
Costochondritis-non-SAE, NR, Mod	0	1
Cough-non-SAE, NR, Mild	3	6
Cough-non-SAE, NR, Mod	0	2
Cough-non-SAE, RIGIV, Mild	1	0
Cushingoid-non-SAE, NR, Mild	0	1
Cystitis-non-SAE, NR, Mild	0	1
Deafness Neurosensory-non-SAE, NR, Mild	1	0
Decreased Appetite-non-SAE, NR, Mild	1	1
Decreased Appetite-non-SAE, RrHu, Mild	0	1
Decreased Appetite-non-SAE, Rboth, Mild	0	2
Dehydration-non-SAE, NR, Mod	0	2
Dental Caries-non-SAE, NR, Mild	0	2
Dental Caries-non-SAE, NR, Mod	0	3
Depressed Mood-non-SAE, NR, Mild	0	1
Depression-non-SAE, NR, Severe	0	1
Dermal Cyst-non-SAE, NR, Mild	0	1
Dermatitis-non-SAE, NR, Mild	0	2
Dermatitis-non-SAE, NR, Mod	1	0
Dermatitis Acneiform-non-SAE, NR, Mod	1	0
Dermatitis Contact-non-SAE, NR, Mild	0	2
Dermatitis Contact-non-SAE, NR, Mod	2	2
Dermatitis Infected-non-SAE, NR, Mild	0	2
Dermatitis Infected-non-SAE, NR, Mod	0	1
Dermatitis Infected-non-SAE, NR, Severe	0	1
Device Failure-non-SAE, NR, Mild	2	1
Device Failure-non-SAE, NR, Mod	0	2
Diarrhoea-non-SAE, NR, Mild	3	6
Diarrhoea-non-SAE, NR, Mod	2	4
Diarrhoea-non-SAE, RIGIV, Mild	1	1
Diarrhoea-non-SAE, RIGIV, Mod	1	0
Diarrhoea Haemorrhagic-non-SAE, NR, Mild	1	0
Diarrhoea Infectious-non-SAE, NR, Mild	0	1
Diastolic Dysfunction-non-SAE, NR, Mild	0	1
Disaccharide Metabolism Disorder-non-SAE, NR, Mild	0	1
Disturbance in Attention-non-SAE, NR, Mild	0	2
Diverticulitis-non-SAE, NR, Mod	1	0
Dizziness-non-SAE, NR, Mild	2	7
Dizziness-non-SAE, NR, Mod	0	2
Dizziness-non-SAE, RIGIV, Mild	0	3
Dizziness-non-SAE, RIGIV, Mod	1	0
Drug Eruption-non-SAE, NR, Mod	1	0
Dry Eye-non-SAE, NR, Mod	0	1
Dry Mouth-non-SAE, NR, Mild	0	1
Dry Skin-non-SAE, NR, Mild	0	3
Dysmenorrhoea-non-SAE, NR, Mild	0	1
Dyspepsia-non-SAE, NR, Mild	0	2
Dyspepsia-non-SAE, NR, Mod	0	1
Dyspepsia-non-SAE, RIGIV, Mild	1	0
Dysphagia-non-SAE, NR, Mild	0	1
Dysphagia-non-SAE, NR, Mod	0	1
Dyspnoea-non-SAE, NR, Mild	1	0
Dyspnoea-non-SAE, NR, Mod	1	0
Dyspnoea-non-SAE, RIGIV, Mild	1	0
Dysuria-non-SAE, NR, Mild	0	2
Ear Infection-non-SAE, NR, Mild	2	2
Ear Infection-non-SAE, NR, Mod	1	1
Ear Pain-non-SAE, NR, Mild	3	2
Ear Pain-non-SAE, NR, Mod	0	1
Ecchymosis-non-SAE, NR, Mild	0	1
Eczema-non-SAE, NR, Mild	0	1
Eczema-non-SAE, NR, Mod	0	1
Eczema-non-SAE, NR, Severe	1	0
Eosinophil Count-non-SAE, NR, Mild	0	1
Epitaxis-non-SAE, NR, Mild	2	3
Epitaxis-non-SAE, NR, Mod	2	2
Erythema-non-SAE, NR, Mild	1	0
Erythema-non-SAE, RIGIV, Mod	0	1
Erythema-non-SAE, RrHu, Mild	0	1
Erythema-non-SAE, Rboth, Mild	0	1
Erythema-non-SAE, Rboth, Mod	0	1
Eustachian Tube Dysfunction-non-SAE, NR, Mild	1	0
Excoriation-non-SAE, NR, Mild	2	2
Extravasation Blood-non-SAE, Rboth, Mild	0	1
Eye Irritation-non-SAE, NR, Mild	0	1
Eye Pruritus-non-SAE, NR, Mod	0	1
Eye Swelling-non-SAE, NR, Mod	0	1
Fall-non-SAE, NR, Mild	0	1
Fall-non-SAE, NR, Mod	0	1
Fatigue-non-SAE, NR, Mild	1	5
Fatigue-non-SAE, NR, Mod	1	2
Fatigue-non-SAE, RIGIV, Mild	8	8
Fatigue-non-SAE, RIGIV, Mod	0	3
Fatigue-non-SAE, Rboth, Mild	0	3
Feeling Abnormal-non-SAE, Rboth, Mod	0	1
Feeling Cold-non-SAE, RIGIV, Mild	2	0
Flatulence-non-SAE, NR, Mild	0	1
Flatulence-non-SAE, NR, Mod	0	1
Food Poisoning-non-SAE, NR, Mod	0	1
Free Haemoglobin Present-non-SAE, NR, Mild	1	1
Free Haemoglobin Present-non-SAE, NR, Severe	1	0

52. Secondary Outcome

Title	Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M)
Description	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
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Gait Disturbance-non-SAE, NR, Mild	0	1
Gastroenteritis-non-SAE, NR, Mild	0	3
Gastroenteritis-non-SAE, NR, Mod	2	2
Gastroenteritis-non-SAE, RIGIV, Mild	1	0
Gastroenteritis-SAE, NR, Mod	0	1
Gastroenteritis Bacterial-non-SAE, NR, Mod	0	1
Gastroenteritis Viral-non-SAE, NR, Mild	3	6
Gastroenteritis Viral-non-SAE, NR, Mod	0	5
Gastroenteritis Viral-non-SAE, RIGIV, Mild	0	1
Gastrointestinal Haemorrhage-non-SAE, NR, Severe	0	1
Gastrooesophageal Reflux Disease-non-SAE, NR, Mild	1	2
Gastrooesophageal Reflux Disease-non-SAE, NR, Mod	1	0
Genital Herpes-non-SAE, NR, Mild	1	0
Genital Swelling-non-SAE, Rboth, Mod	0	1
Goitre-non-SAE, NR, Mild	1	0
Gout-non-SAE, NR, Mild	0	1
Grand Mal Convulsion-non-SAE, NR, Severe	1	0
Grand Mal Convulsion-SAE, NR, Severe	0	1
Gravitational Oedema-non-SAE, Rboth, Mod	0	1
Groin Pain-non-SAE, NR, Mild	0	1
Groin Pain-non-SAE, RIGIV, Mild	0	1
Groin Pain-non-SAE, RrHu, Mod	0	1
Haematoma-non-SAE, NR, Mild	1	1
Haematoma-non-SAE, NR, Mod	0	1
Haematuria-non-SAE, NR, Mild	0	1
Haemoglobin Abnormal-non-SAE, NR, Mild	0	1
Haemorrhoids-non-SAE, NR, Mild	0	2
Hand Fracture-non-SAE, NR, Mod	0	1
Headache-non-SAE, NR, Mild	13	16
Headache-non-SAE, NR, Mod	1	3
Headache-non-SAE, NR, Severe	1	0
Headache-non-SAE, RIGIV, Mild	25	14
Headache-non-SAE, RIGIV, Mod	12	5
Headache-non-SAE, RIGIV, Severe	1	0
Headache-non-SAE, Rboth, Mild	0	9
Headache-non-SAE, Rboth, Mod	0	8
Headache-SAE, NR, Severe	0	1
Hearing Impaired-non-SAE, NR, Mild	0	1
Heart Rate Increased-non-SAE, RIGIV, Mild	4	0
Heat Rash-non-SAE, NR, Mild	0	1
Heat Stroke-non-SAE, NR, Mod	0	1
Herpes Simplex Ophthalmic-non-SAE, NR, Mod	0	1
Herpes Zoster-non-SAE, NR, Mod	0	1
Hiatus Hernia-non-SAE, NR, Mod	0	1
Hot Flush-non-SAE, RIGIV, Mild	1	0
Hyperaesthesia-non-SAE, NR, Mild	0	1
Hypercholesterolaemia-non-SAE, NR, Mod	0	1
Hyperkeratosis-non-SAE, NR, Mild	0	1
Hypertension-non-SAE, NR, Mod	0	4
Hypertension-non-SAE, RIGIV, Mild	0	2
Hypertension-non-SAE, RIGIV, Mod	0	1
Hypertonia-non-SAE, NR, Mild	0	1
Hypothyroidism-non-SAE, NR, Mild	0	1
Idiopathic Urticaria-non-SAE, NR, Mod	1	0
Increased Upper Airway Secretion-non-SAE, NR, Mild	2	0
Infected Bites-non-SAE, NR, Mild	0	2
Infected Bites-non-SAE, NR, Mod	1	1
Infection-non-SAE, NR, Mod	0	2
Influenza-non-SAE, NR, Mild	1	2
Influenza-non-SAE, NR, Mod	4	3
Influenza Like Illness-non-SAE, NR, Mild	0	1
Infusion Related Reaction-non-SAE, RIGIV, Mild	0	1
Infusion Related Reaction-non-SAE, RIGIV, Mod	1	0
Infusion Related Reaction-non-SAE, Rboth, Mild	0	1
Infusion Related Reaction-non-SAE, Rboth, Mod	0	1
Infusion Site Discomfort-non-SAE, RIGIV, Mild	0	6
Infusion Site Discomfort-non-SAE, RrHu, Mod	0	1
Infusion Site Discomfort-non-SAE, Rboth, Mild	0	15
Infusion Site Discomfort-non-SAE, Rboth, Mod	0	8
Infusion Site Erythema-non-SAE, RIGIV, Mild	0	1
Infusion Site Erythema-non-SAE, RrHu, Mild	0	2
Infusion Site Erythema-non-SAE, Rboth, Mild	0	20
Infusion Site Erythema-non-SAE, Rboth, Mod	0	5
Infusion Site Extravasation-non-SAE, NR, Mild	2	0
Infusion Site Haematoma-non-SAE, RIGIV, Mild	0	1
Infusion Site Haemorrhage-non-SAE, Rboth, Mild	0	1
Infusion Site Hypersensitivity-non-SAE, NR, Severe	0	1
Infusion Site Hypersensitivity-non-SAE, Rboth, Mod	0	1
Infusion Site Mass-non-SAE, RIGIV, Mild	0	1
Infusion Site Mass-non-SAE, Rboth, Mild	0	2
Infusion Site Oedema-non-SAE, Rboth, Mild	0	4
Infusion Site Oedema-non-SAE, Rboth, Mod	0	5
Infusion Site Pain-non-SAE, NR, Mild	0	2
Infusion Site Pain-non-SAE, RIGIV, Mild	1	12
Infusion Site Pain-non-SAE, RIGIV, Mod	0	6
Infusion Site Pain-non-SAE, RrHu, Mild	0	35
Infusion Site Pain-non-SAE, RrHu, Mod	0	1
Infusion Site Pain-non-SAE, Rboth, Mild	0	19
Infusion Site Pain-non-SAE, Rboth, Mod	0	16
Infusion Site Pain-non-SAE, Rboth, Severe	0	1
Infusion Site Pruritus-non-SAE, RIGIV, Mild	0	2
Infusion Site Pruritus-non-SAE, RrHu, Mild	0	5
Infusion Site Pruritus-non-SAE, Rboth, Mild	0	6
Infusion Site Pruritus-non-SAE, Rboth, Mod	0	4
Infusion Site Reaction-non-SAE, Rboth, Mild	0	1
Infusion Site Reaction-non-SAE, Rboth, Mod	0	2
Infusion Site Swelling-non-SAE, RIGIV, Mild	0	2
Infusion Site Swelling-non-SAE, Rboth, Mild	0	3
Infusion Site Swelling-non-SAE, Rboth, Mod	0	4
Infusion Site Swelling-non-SAE, Rboth, Severe	0	1
Infusion Site Warmth-non-SAE, Rboth, Mild	0	2
Ingrowing Nail-non-SAE, NR, Mod	0	1
Injection Site Erythema-non-SAE, RIGIV, Mild	0	1
Injury-non-SAE, NR, Mild	1	0
Insomnia-non-SAE, NR, Mild	1	0
Intervertebral Disc Protrusion-non-SAE, NR, Mod	1	0
Irritable Bowel Syndrome-non-SAE, NR, Mild	0	1
Irritable Bowel Syndrome-non-SAE, NR, Mod	0	2
Joint Effusion-non-SAE, NR, Mild	0	1
Joint Effusion-non-SAE, NR, Mod	0	1
Joint Injury-non-SAE, NR, Mod	1	1
Joint Range of Motion Decreased-non-SAE, NR, Mod	0	2
Joint Sprain-non-SAE, NR, Mild	0	1
Joint Sprain-non-SAE, NR, Mod	0	2
Joint Swelling-non-SAE, NR, Mild	0	1
Jugular Vein Distension-non-SAE, NR, Mild	0	1
Lethargy-non-SAE, NR, Mild	0	1
Lethargy-non-SAE, RIGIV, Mod	1	0
Ligament Injury-non-SAE, NR, Mod	0	1
Ligament Sprain-non-SAE, NR, Mod	0	1
Limb Injury-non-SAE, NR, Mild	1	0
Lip Injury-non-SAE, NR, Mild	0	1
Lip Ulceration-non-SAE, NR, Mild	0	1
Local Swelling-non-SAE, RIGIV, Mild	0	3
Local Swelling-non-SAE, Rboth, Mild	0	3
Localised Infection-non-SAE, NR, Mild	0	1
Localised Oedema-non-SAE, RIGIV, Mild	0	1
Localised Oedema-non-SAE, Rboth, Mod	0	1
Lung Infection-non-SAE, NR, Mod	1	0
Lung Infection-non-SAE, NR, Severe	1	0
Lymph Gland Infection-non-SAE, NR, Mod	1	0
Lymph Node Pain-non-SAE, NR, Mild	1	0
Lymph Node Pain-non-SAE, NR, Mod	0	1
Lymph Node Palpable-non-SAE, NR, Mild	1	0
Lymphadenitis-non-SAE, NR, Mod	1	0
Lymphadenopathy-non-SAE, NR, Mild	2	8
Lymphangitis-non-SAE, NR, Mod	0	1
Lymphocyte Count Decreased-non-SAE, RIGIV, Mild	0	1
Lymphoedema-non-SAE, NR, Severe	1	0
Malaise-non-SAE, NR, Mild	0	2
Malaise-non-SAE, NR, Mod	0	1
Malaise-non-SAE, RIGIV, Mod	1	0
Malaise-non-SAE, RrHu, Mild	0	1
Malaise-non-SAE, RrHu, Mod	0	1
Memory Impairment-non-SAE, NR, Mod	0	1
Migraine-non-SAE, NR, Mild	1	1
Migraine-non-SAE, NR, Mod	0	2
Migraine-non-SAE, NR, Severe	1	0
Migraine-non-SAE, RIGIV, Mild	1	1
Migraine-non-SAE, RIGIV, Mod	1	4
Migraine-non-SAE, RIGIV, Severe	0	1
Migraine-non-SAE, Rboth, Mod	0	1
Molluscum Contagiosum-non-SAE, NR, Mild	2	0
Mouth Ulceration-non-SAE, NR, Mild	1	0
Multiple Sclerosis Relapse-non-SAE, NR, Mod	0	1
Muscle Fatigue-non-SAE, NR, Mild	0	1
Muscle Injury-non-SAE, NR, Mild	0	2
Muscle Spasms-non-SAE, NR, Mild	0	1
Muscle Spasms-non-SAE, RIGIV, Mild	1	0
Muscle Strain-non-SAE, NR, Mild	1	1
Muscle Strain-non-SAE, NR, Mod	0	1
Muscular Weakness-non-SAE, NR, Mild	1	0
Musculoskeletal Chest Pain-non-SAE, NR, Mild	0	1
Musculoskeletal Chest Pain-non-SAE, RIGIV, Mild	0	1
Musculoskeletal Pain-non-SAE, NR, Mild	2	0
Musculoskeletal Pain-non-SAE, NR, Mod	1	1
Musculoskeletal Stiffness-non-SAE, NR, Mild	1	1
Myalgia-non-SAE, NR, Mild	3	5
Myalgia-non-SAE, NR, Mod	1	4
Myalgia-non-SAE, NR, Severe	0	1
Myalgia-non-SAE, RIGIV, Mild	0	6
Myalgia-non-SAE, RIGIV, Mod	1	1
Myalgia-non-SAE, Rboth, Mild	0	3

53. Secondary Outcome

Title	Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z)
Description	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
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Nasal Congestion-non-SAE, NR, Mild	4	3
Nasal Congestion-non-SAE, NR, Mod	0	2
Nasal Congestion-non-SAE, RIGIV, Mild	0	3
Nasal Discomfort-non-SAE, NR, Mild	0	1
Nasal Mucosal Discolouration-non-SAE, NR, Mild	0	1
Nasal Turbinate Hypertrophy-non-SAE, NR, Mild	0	1
Nasopharyngitis-non-SAE, NR, Mild	4	8
Nausea-non-SAE, NR, Mild	3	17
Nausea-non-SAE, NR, Mod	2	3
Nausea-non-SAE, RIGIV, Mild	7	1
Nausea-non-SAE, RIGIV, Mod	1	0
Nausea-non-SAE, Rboth, Mild	0	4
Neck Pain-non-SAE, NR, Mild	1	1
Night Sweats-non-SAE, NR, Mild	1	0
Night Sweats-non-SAE, NR, Mod	0	1
Nodule-non-SAE, Rboth, Mild	0	2
Oedema-non-SAE, RIGIV, Mild	0	1
Oedema Genital-non-SAE, Rboth, Severe	0	1
Oedema Peripheral-non-SAE, NR, Mild	0	1
Oedema Peripheral-non-SAE, NR, Mod	0	1
Oedema Peripheral-non-SAE, Rboth, Mod	0	2
Oesophagitis-non-SAE, NR, Mild	0	1
Onychomycosis-non-SAE, NR, Mild	0	1
Oral Candidiasis-non-SAE, NR, Mod	0	1
Oral Fungal Infection-non-SAE, NR, Mild	0	1
Oral Herpes-non-SAE, NR, Mild	1	2
Oral Herpes-non-SAE, NR, Mod	0	1
Oral Pain-non-SAE, NR, Mild	0	1
Oral Pain-non-SAE, RrHu, Severe	0	1
Oropharyngeal Pain-non-SAE, NR, Mild	1	4
Oropharyngeal Pain-non-SAE, NR, Mod	2	1
Osteoarthritis-non-SAE, NR, Mod	0	1
Osteopenia-non-SAE, NR, Mild	0	1
Osteopenia-non-SAE, NR, Mod	0	1
Osteoporosis-non-SAE, NR, Mild	0	1
Otitis Externa-non-SAE, NR, Mild	0	1
Otitis Externa-non-SAE, NR, Mod	0	1
Otitis Media-non-SAE, NR, Mod	1	1
Pain-non-SAE, NR, Mild	1	5
Pain-non-SAE, NR, Mod	1	1
Pain-non-SAE, RIGIV, Mild	0	1
Pain-non-SAE, RIGIV, Mod	2	1
Pain-non-SAE, Rboth, Mild	0	1
Pain-non-SAE, Rboth, Mod	0	1
Pain in Extremity-non-SAE, NR, Mild	2	1
Pain in Extremity-non-SAE, NR, Mod	1	2
Pain in Extremity-non-SAE, RIGIV, Mod	2	0
Pain in Extremity-non-SAE, RIGIV, Severe	1	0
Pain in Extremity-non-SAE, Rboth, Mild	0	3
Pain in Extremity-non-SAE, Rboth, Mod	0	2
Palpitations-non-SAE, NR, Mild	1	1
Papule-non-SAE, NR, Mild	0	1
Peptic Ulcer Haemorrhage-SAE, NR, Severe	1	0
Periorbital Haematoma-non-SAE, NR, Mild	0	1
Peripheral Nerve Injury-non-SAE, NR, Mild	0	1
Pertussis-non-SAE, NR, Mod	0	1
Petit Mal Epilepsy-SAE, NR, Severe	0	1
Pharyngeal Erythema-non-SAE, NR, Mild	1	3
Pharyngitis-non-SAE, NR, Mild	1	4
Pharyngitis-non-SAE, NR, Mod	1	0
Pharyngitis Streptococcal-non-SAE, NR, Mod	0	4
Pneumonia-non-SAE, NR, Mild	0	1
Pneumonia-non-SAE, NR, Mod	0	1
Pneumonia Bacterial-non-SAE, NR, Mod	0	1
Post Procedural Infection-non-SAE, NR, Mild	1	2
Post Procedural Infection-non-SAE, NR, Mod	0	5
Postictal Paralysis-non-SAE, NR, Mod	0	1
Postoperative Wound Infection-non-SAE, NR, Mod	0	1
Procedural Pain-non-SAE, NR, Mild	0	2
Procedural Pain-non-SAE, NR, Mod	0	1
Productive Cough-non-SAE, NR, Mild	1	1
Pruritus-non-SAE, NR, Mild	1	0
Pruritus-non-SAE, RIGIV, Mild	1	0
Pruritus-non-SAE, Rboth, Mild	0	1
Pruritus-non-SAE, Rboth, Mod	0	1
Pruritus Generalized-non-SAE, NR, Mild	1	0
Pseudomonas Infection-non-SAE, NR, Mod	0	1
Psoriasis-non-SAE, NR, Mod	0	1
Pyrexia-non-SAE, NR, Mild	3	11
Pyrexia-non-SAE, NR, Mod	2	1
Pyrexia-non-SAE, RIGIV, Mild	4	6
Pyrexia-non-SAE, RIGIV, Mod	2	2
Pyrexia-non-SAE, Rboth, Mild	0	2
Rales-non-SAE, NR, Mild	0	1
Rales-non-SAE, NR, Mod	0	1
Rash-non-SAE, NR, Mild	2	5
Rash-non-SAE, NR, Mod	0	1
Rash Erythematous-non-SAE, NR, Mild	0	1
Rash Macro-Papular-non-SAE, Rboth, Mild	0	1
Rash Pustular-non-SAE, NR, Mild	0	1
Rash Pustular-non-SAE, NR, Mod	1	0
Rash Papular-non-SAE, NR, Mild	0	1
Respiratory Failure-SAE, NR, Severe	0	1
Respiratory Rate Increased-non-SAE, NR, Mild	0	1
Respiratory Tract Congestion-non-SAE, NR, Mild	0	1
Respiratory Tract Infection-non-SAE, NR, Mild	1	1
Respiratory Tract Infection-non-SAE, NR, Mod	1	3
Respiratory Tract Infection Viral-non-SAE, NR, Mod	1	0
Rhinitis Allergic-non-SAE, NR, Mild	1	3
Rhinitis Allergic-non-SAE, NR, Mod	3	1
Rhinitis Allergic-non-SAE, RIGIV, Mod	1	0
Rhinorrhoea-non-SAE, NR, Mild	1	1
Road Traffic Accident-non-SAE, NR, Mod	0	2
Scleritis-non-SAE, NR, Mild	1	1
Scleritis-non-SAE, NR, Mod	0	1
Scratch-non-SAE, NR, Mild	1	0
Seborrhoeic Dermatitis-non-SAE, NR, Mild	0	1
Sicca Syndrome-non-SAE, NR, Mod	0	1
Sinus Congestion-non-SAE, NR, Mild	1	0
Sinus Headache-non-SAE, NR, Mild	1	0
Sinusitis-non-SAE, NR, Mild	6	25
Sinusitis-non-SAE, NR, Mod	13	26
Sinusitis-non-SAE, NR, Severe	0	1
Sinusitis-non-SAE, RIGIV, Mod	0	1
Skeletal Injury-non-SAE, NR, Mild	0	1
Skeletal Injury-non-SAE, NR, Mod	0	1
Skin Hyperpigmentation-non-SAE, Rboth, Mild	0	1
Skin Laceration-non-SAE, NR, Mild	0	1
Skin Laceration-non-SAE, NR, Mod	0	1
Skin Lesion-non-SAE, NR, Mild	2	1
Skin Lesion-non-SAE, NR, Mod	1	0
Skin Lesion-non-SAE, RIGIV, Mild	0	2
Skin Papilloma-non-SAE, NR, Mod	1	0
Spinal Osteoarthritis-non-SAE, NR, Mild	0	2
Squamous Cell Carcinoma-non-SAE, NR, Mod	1	1
Status Epilepticus-SAE, NR, Severe	0	1
Suicidal Ideation-non-SAE, NR, Mild	1	0
Sunburn-non-SAE, NR, Mild	0	1
Swelling-non-SAE, Rboth, Mild	0	1
Swelling-non-SAE, Rboth, Mod	0	3
Syncope-non-SAE, NR, Mild	0	1
Tachycardia-non-SAE, NR, Mild	0	3
Tachycardia-non-SAE, NR, Mod	0	1
Therapy Cessation-non-SAE, NR, Severe	0	1
Thrombosis-non-SAE, NR, Severe	0	1
Thrombosis-SAE, NR, Mod	0	1
Tinea Infection-non-SAE, NR, Mild	2	0
Tongue Coated-non-SAE, NR, Mild	0	1
Tonsillar Hypertrophy-non-SAE, NR, Mod	0	1
Tonsillar Hypertrophy-SAE, NR, Mild	0	1
Tooth Abscess-non-SAE, NR, Mild	1	0
Tooth Abscess-non-SAE, NR, Mod	0	1
Tooth Impacted-non-SAE, NR, Mod	0	1
Tooth Infection-non-SAE, NR, Mod	0	1
Toothache-non-SAE, NR, Mod	0	1
Tongue Injury-non-SAE, NR, Mild	0	1
Tremor-non-SAE, NR, Mild	0	1
Tricuspid Valve Incompetence-non-SAE, NR, Mild	0	1
Tympanic Membrane Disorder-non-SAE, NR, Mild	1	0
Tympanic Membrane Hyperaemia-non-SAE, NR, Mild	0	2
Upper Airway Cough Syndrome-non-SAE, NR, Mild	0	1
Upper Resp. Tract Infection-non-SAE, NR, Mild	7	34
Upper Resp. Tract Infection-non-SAE, NR, Mod	2	10
Urinary Tract Infection-non-SAE, NR, Mild	1	2
Urinary Tract Infection-non-SAE, NR, Mod	5	4
Urine Analysis Abnormal-non-SAE, NR, Mild	0	1
Urticaria-non-SAE, NR, Mild	0	5
Urticaria-non-SAE, NR, Mod	0	1
Urticaria-non-SAE, RIGIV, Mild	1	0
Uterine Polyp-non-SAE, NR, Mod	0	1
Vaginal Haemorrhage-non-SAE, NR, Mod	0	1
Vascular Access Complication-non-SAE, NR, Mild	1	0
Vertigo-non-SAE, NR, Mod	0	1
Viral Diarrhoea-non-SAE, NR, Mild	0	1
Viral Infection-non-SAE, NR, Mild	3	7
Viral Infection-non-SAE, NR, Mod	3	3
Viral Infection-SAE, NR, Mild	1	0
Viral Upper Resp. Tract Infection-non-SAE, NR Mild	1	8
Viral Upper Resp. Tract Infection-non-SAE, NR, Mod	1	1
Vision Blurred-non-SAE, NR, Mild	0	1
Vitamin D Deficiency-non-SAE, NR, Mild	1	0
Vitamin D Deficiency-non-SAE, NR, Mod	0	2
Vomiting-non-SAE, NR, Mild	5	7
Vomiting-non-SAE, NR, Mod	0	3
Vomiting-non-SAE, RIGIV, Mild	4	3
Vomiting-non-SAE, RIGIV, Mod	1	4
Vomiting-non-SAE, RIGIV, Severe	1	0
Vomiting-non-SAE, Rboth, Mod	0	1
Vulvovaginal Pruritus-non-SAE, RIGIV, Mild	0	1
Weight Decreased-non-SAE, RrHu, Mild	0	1
Weight Decreased-non-SAE, RrHu, Mod	0	1
Wheezing-non-SAE, NR, Mod	0	1
WBC Count Decreased-non-SAE, RIGIV, Mild	0	1
White Blood Cells Urine Positive-non-SAE, NR, Mild	0	1
WBC Urine Positive-non-SAE, RIGIV Mild	1	0

54. Secondary Outcome

Title	Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F)
Description	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
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Measure Infusions	365	1129
Abdominal Discomfort-non-SAE, NR, Mod	0	0.001
Abdominal Distension-non-SAE, Rboth, Mild	0	0.001
Abdominal Hernia-non-SAE, NR, Mild	0	0.001
Abdominal Pain-non-SAE, NR, Mild	0.003	0.002
Abdominal Pain-non-SAE, NR, Mod	0	0.001
Abdominal Pain-non-SAE, Rboth, Mild	0	0.003
Abdominal Pain-non-SAE, Rboth, Mod	0	0.001
Abdominal Pain Lower-non-SAE, NR, Mild	0	0.001
Abdominal Pain Upper-non-SAE, NR, Mild	0.003	0.004
Abdominal Pain Upper-non-SAE, NR, Mod	0.003	0
Abdominal Pain Upper-non-SAE, RIGIV, Mild	0	0.001
Abdominal Pain Upper-non-SAE, RIGIV, Mod	0.003	0
Abdominal Pain Upper-non-SAE, Rboth, Mild	0	0.002
Abdominal Tenderness-non-SAE, NR, Mod	0.003	0
Abdominal Tenderness-non-SAE, RIGIV, Mild	0	0.001
Abdominal Tenderness-non-SAE, RIGIV, Mod	0	0.002
Acarodermatitis-non-SAE, NR, Mild	0	0.001
Acne-non-SAE, NR, Mild	0.003	0.001
Acute Sinusitis-non-SAE, NR, Mild	0.003	0
Acute Sinusitis-non-SAE, NR, Mod	0	0.004
Adenoidal Hypertrophy-non-SAE, NR, Mod	0	0.001
Adnexa Uteri Cyst-non-SAE, NR, Mild	0.003	0
Adrenocortical Insufficiency Acute-SAE, NR, Mod	0	0.001
Allergic Respiratory Symptom-non-SAE, NR, Mild	0	0.001
Allergic Sinusitis-non-SAE, NR, Mild	0.003	0
Alopecia-non-SAE, NR, Mild	0.003	0
Animal Bite-non-SAE, NR, Mod	0.003	0
Antibody Test Positive-non-SAE, Rboth, Mod	0	0.001
Anxiety-non-SAE, NR, Mild	0	0.001
Anxiety-non-SAE, NR, Mod	0.003	0
Aphthous Stomatitis-non-SAE, NR, Mild	0.005	0.001
Aphthous Stomatitis-non-SAE, NR, Mod	0	0.001
Arteriosclerosis Coronary Artery-non-SAE, NR, Mild	0	0.001
Arthralgia-non-SAE, NR, Mild	0	0.004
Arthralgia-non-SAE, NR, Mod	0.003	0.005
Arthralgia-non-SAE, RIGIV, Mild	0	0.001
Arthralgia-non-SAE, RIGIV, Mod	0	0.002
Arthritis-non-SAE, NR, Mod	0.003	0.001
Arthropathy-non-SAE, NR, Mod	0.003	0
Arthropod Bite-non-SAE, NR, Mild	0.005	0.002
Arthropod Sting-non-SAE, NR, Mild	0	0.001
Arthropod Sting-non-SAE, NR, Mod	0.003	0
Aspiration-non-SAE, NR, Mild	0	0.001
Asthenia-non-SAE, NR, Mild	0	0.003
Asthenia-non-SAE, NR, Mod	0.003	0
Asthenia-non-SAE, RIGIV, Mild	0	0.001
Asthma-non-SAE, NR, Mild	0	0.004
Asthma-non-SAE, NR, Mod	0.022	0.019
Asthma-non-SAE, NR, Severe	0	0.001
ADHD-non-SAE, NR, Mod	0	0.001
Back Injury-non-SAE, NR, Mod	0.003	0
Back Injury-SAE, NR, Severe	0	0.001
Back Pain-non-SAE, NR, Mild	0.003	0.002
Back Pain-non-SAE, NR, Mod	0.003	0.004
Bacterial Prostatitis-non-SAE, NR, Mild	0	0.001
Blepharitis-non-SAE, NR, Mod	0.003	0
Blister-non-SAE, NR, Mild	0	0.001
Blood Pressure Decreased-non-SAE, NR, Mild	0	0.001
Blood Pressure Decreased-non-SAE, Rboth, Mild	0	0.001
Blood Pressure Increased-non-SAE, NR, Mod	0	0.001
Blood Pressure Increased-non-SAE, RIGIV, Mild	0	0.001
Blood Pressure Increased-non-SAE, RIGIV, Mod	0	0.001
Blood Pressure Increased-non-SAE, RrHu, Mild	0	0.001
BP Systolic Increased-non-SAE, RIGIV, Mild	0.003	0
Blood Urea Increased-non-SAE, NR, Mild	0	0.001
Body Fat Disorder-non-SAE, NR, Mild	0	0.001
Body Tinea-non-SAE, NR, Mild	0.003	0
Body Tinea-non-SAE, NR, Mod	0	0.001
Bone Pain-non-SAE, NR, Mild	0	0.001
Breast Pain-non-SAE, NR, Mild	0.003	0
Bronchal Hyperreactivity-non-SAE, NR, Mild	0	0.001
Bronchitis-non-SAE, NR, Mild	0.011	0.002
Bronchitis-non-SAE, NR, Mod	0.005	0.007
Bronchitis-SAE, NR, Mod	0.003	0
Bronchospasm-non-SAE, NR, Mod	0	0.001
Burn Infection-non-SAE, NR, Mild	0	0.001
Burning Sensation-non-SAE, RIGIV, Mild	0	0.001
Burning Sensation-non-SAE, RIGIV, Mod	0	0.001
Burning Sensation-non-SAE, RrHu, Mild	0	0.001
Bursitis-non-SAE, NR, Mild	0.003	0
Bursitis-non-SAE, NR, Mod	0	0.001
Candidiasis-non-SAE, NR, Mild	0.003	0
Candidiasis-non-SAE, NR, Mod	0.003	0.001
Cardiac Murmur-non-SAE, NR, Mild	0	0.001
Cellulitis-non-SAE, NR, Mild	0	0.001
Cellulitis-non-SAE, NR, Mod	0	0.003
Cellulitis-non-SAE, Rboth, Mod	0	0.001
Cerumen Impaction-non-SAE, NR, Mild	0	0.002
Cervical Dysplasia-SAE, NR, Mild	0.003	0.001
Cheilitis-non-SAE, NR, Mild	0.005	0
Chest Pain-non-SAE, NR, Mild	0	0.002
Chills-non-SAE, NR, Mild	0	0.003
Chills-non-SAE, RIGIV, Mild	0.016	0.001
Chills-non-SAE, RIGIV, Mod	0.008	0
Chills-non-SAE, Rboth, Mild	0	0.001
COPD-non-SAE, NR, Mod	0	0.002
COPD-non-SAE, NR, Severe	0.003	0
Chronic Sinusitis-non-SAE, NR, Mild	0	0.004
Chronic Sinusitis-non-SAE, NR, Mod	0.003	0.001
Concussion-non-SAE, NR, Mod	0.003	0
Confusional State-non-SAE, NR, Mod	0	0.001
Confusional State-non-SAE, RIGIV, Mild	0.003	0
Conjunctivitis-non-SAE, NR, Mild	0.003	0.002
Conjunctivitis Allergic-non-SAE, NR, Mild	0.003	0
Conjunctivitis Allergic-non-SAE, NR, Mod	0.003	0
Conjunctivitis Bacterial-non-SAE, NR, Mild	0.003	0.001
Conjunctivitis Bacterial-non-SAE, NR, Mod	0	0.001
Conjunctivitis Bacterial-non-SAE, NR, Severe	0	0.001
Constipation-non-SAE, NR, Mild	0	0.003
Contusion-non-SAE, NR, Mild	0.003	0.004
Contusion-non-SAE, NR, Mod	0.003	0
Contusion-non-SAE, RIGIV, Mod	0	0.001
Coombs Test Positive-non-SAE, RIGIV, Mild	0	0.001
Costochondritis-non-SAE, NR, Mod	0	0.001
Cough-non-SAE, NR, Mild	0.008	0.005
Cough-non-SAE, NR, Mod	0	0.002
Cough-non-SAE, RIGIV, Mild	0.003	0
Cushingoid-non-SAE, NR, Mild	0	0.001
Cystitis-non-SAE, NR, Mild	0	0.001
Deafness Neurosensory-non-SAE, NR, Mild	0.003	0
Decreased Appetite-non-SAE, NR, Mild	0.003	0.001
Decreased Appetite-non-SAE, RrHu, Mild	0	0.001
Decreased Appetite-non-SAE, Rboth, Mild	0	0.002
Dehydration-non-SAE, NR, Mod	0	0.002
Dental Caries-non-SAE, NR, Mild	0	0.002
Dental Caries-non-SAE, NR, Mod	0	0.003
Depressed Mood-non-SAE, NR, Mild	0	0.001
Depression-non-SAE, NR, Severe	0	0.001
Dermal Cyst-non-SAE, NR, Mild	0	0.001
Dermatitis-non-SAE, NR, Mild	0	0.002
Dermatitis-non-SAE, NR, Mod	0.003	0
Dermatitis Acneiform-non-SAE, NR, Mod	0.003	0
Dermatitis Contact-non-SAE, NR, Mild	0	0.002
Dermatitis Contact-non-SAE, NR, Mod	0.005	0.002
Dermatitis Infected-non-SAE, NR, Mild	0	0.002
Dermatitis Infected-non-SAE, NR, Mod	0	0.001
Dermatitis Infected-non-SAE, NR, Severe	0	0.001
Device Failure-non-SAE, NR, Mild	0.005	0.001
Device Failure-non-SAE, NR, Mod	0	0.002
Diarrhoea-non-SAE, NR, Mild	0.008	0.005
Diarrhoea-non-SAE, NR, Mod	0.005	0.004
Diarrhoea-non-SAE, RIGIV, Mild	0.003	0.001
Diarrhoea-non-SAE, RIGIV, Mod	0.003	0
Diarrhoea Haemorrhagic-non-SAE, NR, Mild	0.003	0
Diarrhoea Infectious-non-SAE, NR, Mild	0	0.001
Diastolic Dysfunction-non-SAE, NR, Mild	0	0.001
Disaccharide Metabolism Disorder-non-SAE, NR, Mild	0	0.001
Disturbance in Attention-non-SAE, NR, Mild	0	0.002
Diverticulitis-non-SAE, NR, Mod	0.003	0
Dizziness-non-SAE, NR, Mild	0.005	0.006
Dizziness-non-SAE, NR, Mod	0	0.002
Dizziness-non-SAE, RIGIV, Mild	0	0.003
Dizziness-non-SAE, RIGIV, Mod	0.003	0
Drug Eruption-non-SAE, NR, Mod	0.003	0
Dry Eye-non-SAE, NR, Mod	0	0.001
Dry Mouth-non-SAE, NR, Mild	0	0.001
Dry Skin-non-SAE, NR, Mild	0	0.003
Dysmenorrhoea-non-SAE, NR, Mild	0	0.001
Dyspepsia-non-SAE, NR, Mild	0	0.002
Dyspepsia-non-SAE, NR, Mod	0	0.001
Dyspepsia-non-SAE, RIGIV, Mild	0.003	0
Dysphagia-non-SAE, NR, Mild	0	0.001
Dysphagia-non-SAE, NR, Mod	0	0.001
Dyspnoea-non-SAE, NR, Mild	0.003	0
Dyspnoea-non-SAE, NR, Mod	0.003	0
Dyspnoea-non-SAE, RIGIV, Mild	0.003	0
Dysuria-non-SAE, NR, Mild	0	0.002
Ear Infection-non-SAE, NR, Mild	0.005	0.002
Ear Infection-non-SAE, NR, Mod	0.003	0.001
Ear Pain-non-SAE, NR, Mild	0.008	0.002
Ear Pain-non-SAE, NR, Mod	0	0.001
Ecchymosis-non-SAE, NR, Mild	0	0.001
Eczema-non-SAE, NR, Mild	0	0.001
Eczema-non-SAE, NR, Mod	0	0.001
Eczema-non-SAE, NR, Severe	0.003	0
Eosinophil Count-non-SAE, NR, Mild	0	0.001
Epitaxis-non-SAE, NR, Mild	0.005	0.003
Epitaxis-non-SAE, NR, Mod	0.005	0.002
Erythema-non-SAE, NR, Mild	0.003	0
Erythema-non-SAE, RIGIV, Mod	0	0.001
Erythema-non-SAE, RrHu, Mild	0	0.001
Erythema-non-SAE, Rboth, Mild	0	0.001
Erythema-non-SAE, Rboth, Mod	0	0.001
Eustachian Tube Dysfunction-non-SAE, NR, Mild	0.003	0
Excoriation-non-SAE, NR, Mild	0.005	0.002
Extravasation Blood-non-SAE, Rboth, Mild	0	0.001
Eye Irritation-non-SAE, NR, Mild	0	0.001
Eye Pruritus-non-SAE, NR, Mod	0	0.001
Eye Swelling-non-SAE, NR, Mod	0	0.001
Fall-non-SAE, NR, Mild	0	0.001
Fall-non-SAE, NR, Mod	0	0.001
Fatigue-non-SAE, NR, Mild	0.003	0.004
Fatigue-non-SAE, NR, Mod	0.003	0.002
Fatigue-non-SAE, RIGIV, Mild	0.022	0.007
Fatigue-non-SAE, RIGIV, Mod	0	0.003
Fatigue-non-SAE, Rboth, Mild	0	0.003
Feeling Abnormal-non-SAE, Rboth, Mod	0	0.001
Feeling Cold-non-SAE, RIGIV, Mild	0.005	0
Flatulence-non-SAE, NR, Mild	0	0.001
Flatulence-non-SAE, NR, Mod	0	0.001
Food Poisoning-non-SAE, NR, Mod	0	0.001
Free Haemoglobin Present-non-SAE, NR, Mild	0.003	0.001
Free Haemoglobin Present-non-SAE, NR, Severe	0.003	0

55. Secondary Outcome

Title	Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M)
Description	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
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Measure Infusions	365	1129
Gait Disturbance-non-SAE, NR, Mild	0	0.001
Gastroenteritis-non-SAE, NR, Mild	0	0.003
Gastroenteritis-non-SAE, NR, Mod	0.005	0.002
Gastroenteritis-non-SAE, RIGIV, Mild	0.003	0
Gastroenteritis-SAE, NR, Mod	0	0.001
Gastroenteritis Bacterial-non-SAE, NR, Mod	0	0.001
Gastroenteritis Viral-non-SAE, NR, Mild	0.008	0.005
Gastroenteritis Viral-non-SAE, NR, Mod	0	0.004
Gastroenteritis Viral-non-SAE, RIGIV, Mild	0	0.001
Gastrointestinal Haemorrhage-non-SAE, NR, Severe	0	0.001
Gastrooesophageal Reflux Disease-non-SAE, NR, Mild	0.003	0.002
Gastrooesophageal Reflux Disease-non-SAE, NR, Mod	0.003	0
Genital Herpes-non-SAE, NR, Mild	0.003	0
Genital Swelling-non-SAE, Rboth, Mod	0	0.001
Goitre-non-SAE, NR, Mild	0.003	0
Gout-non-SAE, NR, Mild	0	0.001
Grand Mal Convulsion-non-SAE, NR, Severe	0.003	0
Grand Mal Convulsion-SAE, NR, Severe	0	0.001
Gravitational Oedema-non-SAE, Rboth, Mod	0	0.001
Groin Pain-non-SAE, NR, Mild	0	0.001
Groin Pain-non-SAE, RIGIV, Mild	0	0.001
Groin Pain-non-SAE, RrHu, Mod	0	0.001
Haematoma-non-SAE, NR, Mild	0.003	0.001
Haematoma-non-SAE, NR, Mod	0	0.001
Haematuria-non-SAE, NR, Mild	0	0.001
Haemoglobin Abnormal-non-SAE, NR, Mild	0	0.001
Haemorrhoids-non-SAE, NR, Mild	0	0.002
Hand Fracture-non-SAE, NR, Mod	0	0.001
Headache-non-SAE, NR, Mild	0.036	0.014
Headache-non-SAE, NR, Mod	0.003	0.003
Headache-non-SAE, NR, Severe	0.003	0
Headache-non-SAE, RIGIV, Mild	0.068	0.012
Headache-non-SAE, RIGIV, Mod	0.033	0.004
Headache-non-SAE, RIGIV, Severe	0.003	0
Headache-non-SAE, Rboth, Mild	0	0.008
Headache-non-SAE, Rboth, Mod	0	0.007
Headache-SAE, NR, Severe	0	0.001
Hearing Impaired-non-SAE, NR, Mild	0	0.001
Heart Rate Increased-non-SAE, RIGIV, Mild	0.011	0
Heat Rash-non-SAE, NR, Mild	0	0.001
Heat Stroke-non-SAE, NR, Mod	0	0.001
Herpes Simplex Ophthalmic-non-SAE, NR, Mod	0	0.001
Herpes Zoster-non-SAE, NR, Mod	0	0.001
Hiatus Hernia-non-SAE, NR, Mod	0	0.001
Hot Flush-non-SAE, RIGIV, Mild	0.003	0
Hyperaesthesia-non-SAE, NR, Mild	0	0.001
Hypercholesterolaemia-non-SAE, NR, Mod	0	0.001
Hyperkeratosis-non-SAE, NR, Mild	0	0.001
Hypertension-non-SAE, NR, Mod	0	0.004
Hypertension-non-SAE, RIGIV, Mild	0	0.002
Hypertension-non-SAE, RIGIV, Mod	0	0.001
Hypertonia-non-SAE, NR, Mild	0	0.001
Hypothyroidism-non-SAE, NR, Mild	0	0.001
Idiopathic Urticaria-non-SAE, NR, Mod	0.003	0
Increased Upper Airway Secretion-non-SAE, NR, Mild	0.005	0
Infected Bites-non-SAE, NR, Mild	0	0.002
Infected Bites-non-SAE, NR, Mod	0.003	0.001
Infection-non-SAE, NR, Mod	0	0.002
Influenza-non-SAE, NR, Mild	0.003	0.002
Influenza-non-SAE, NR, Mod	0.011	0.003
Influenza Like Illness-non-SAE, NR, Mild	0	0.001
Infusion Related Reaction-non-SAE, RIGIV, Mild	0	0.001
Infusion Related Reaction-non-SAE, RIGIV, Mod	0.003	0
Infusion Related Reaction-non-SAE, Rboth, Mild	0	0.001
Infusion Related Reaction-non-SAE, Rboth, Mod	0	0.001
Infusion Site Discomfort-non-SAE, RIGIV, Mild	0	0.005
Infusion Site Discomfort-non-SAE, RrHu, Mod	0	0.001
Infusion Site Discomfort-non-SAE, Rboth, Mild	0	0.013
Infusion Site Discomfort-non-SAE, Rboth, Mod	0	0.007
Infusion Site Erythema-non-SAE, RIGIV, Mild	0	0.001
Infusion Site Erythema-non-SAE, RrHu, Mild	0	0.002
Infusion Site Erythema-non-SAE, Rboth, Mild	0	0.018
Infusion Site Erythema-non-SAE, Rboth, Mod	0	0.004
Infusion Site Extravasation-non-SAE, NR, Mild	0.005	0
Infusion Site Haematoma-non-SAE, RIGIV, Mild	0	0.001
Infusion Site Haemorrhage-non-SAE, Rboth, Mild	0	0.001
Infusion Site Hypersensitivity-non-SAE, NR, Severe	0	0.001
Infusion Site Hypersensitivity-non-SAE, Rboth, Mod	0	0.001
Infusion Site Mass-non-SAE, RIGIV, Mild	0	0.001
Infusion Site Mass-non-SAE, Rboth, Mild	0	0.002
Infusion Site Oedema-non-SAE, Rboth, Mild	0	0.004
Infusion Site Oedema-non-SAE, Rboth, Mod	0	0.004
Infusion Site Pain-non-SAE, NR, Mild	0	0.002
Infusion Site Pain-non-SAE, RIGIV, Mild	0.003	0.011
Infusion Site Pain-non-SAE, RIGIV, Mod	0	0.005
Infusion Site Pain-non-SAE, RrHu, Mild	0	0.031
Infusion Site Pain-non-SAE, RrHu, Mod	0	0.001
Infusion Site Pain-non-SAE, Rboth, Mild	0	0.017
Infusion Site Pain-non-SAE, Rboth, Mod	0	0.014
Infusion Site Pain-non-SAE, Rboth, Severe	0	0.001
Infusion Site Pruritus-non-SAE, RIGIV, Mild	0	0.002
Infusion Site Pruritus-non-SAE, RrHu, Mild	0	0.004
Infusion Site Pruritus-non-SAE, Rboth, Mild	0	0.005
Infusion Site Pruritus-non-SAE, Rboth, Mod	0	0.004
Infusion Site Reaction-non-SAE, Rboth, Mild	0	0.001
Infusion Site Reaction-non-SAE, Rboth, Mod	0	0.002
Infusion Site Swelling-non-SAE, RIGIV, Mild	0	0.002
Infusion Site Swelling-non-SAE, Rboth, Mild	0	0.003
Infusion Site Swelling-non-SAE, Rboth, Mod	0	0.004
Infusion Site Swelling-non-SAE, Rboth, Severe	0	0.001
Infusion Site Warmth-non-SAE, Rboth, Mild	0	0.002
Ingrowing Nail-non-SAE, NR, Mod	0	0.001
Injection Site Erythema-non-SAE, RIGIV, Mild	0	0.001
Injury-non-SAE, NR, Mild	0.003	0
Insomnia-non-SAE, NR, Mild	0.003	0
Intervertebral Disc Protrusion-non-SAE, NR, Mod	0.003	0
Irritable Bowel Syndrome-non-SAE, NR, Mild	0	0.001
Irritable Bowel Syndrome-non-SAE, NR, Mod	0	0.002
Joint Effusion-non-SAE, NR, Mild	0	0.001
Joint Effusion-non-SAE, NR, Mod	0	0.001
Joint Injury-non-SAE, NR, Mod	0.003	0.001
Joint Range of Motion Decreased-non-SAE, NR, Mod	0	0.002
Joint Sprain-non-SAE, NR, Mild	0	0.001
Joint Sprain-non-SAE, NR, Mod	0	0.002
Joint Swelling-non-SAE, NR, Mild	0	0.001
Jugular Vein Distension-non-SAE, NR, Mild	0	0.001
Lethargy-non-SAE, NR, Mild	0	0.001
Lethargy-non-SAE, RIGIV, Mod	0.003	0
Ligament Injury-non-SAE, NR, Mod	0	0.001
Ligament Sprain-non-SAE, NR, Mod	0	0.001
Limb Injury-non-SAE, NR, Mild	0.003	0
Lip Injury-non-SAE, NR, Mild	0	0.001
Lip Ulceration-non-SAE, NR, Mild	0	0.001
Local Swelling-non-SAE, RIGIV, Mild	0	0.003
Local Swelling-non-SAE, Rboth, Mild	0	0.003
Localised Infection-non-SAE, NR, Mild	0	0.001
Localised Oedema-non-SAE, RIGIV, Mild	0	0.001
Localised Oedema-non-SAE, Rboth, Mod	0	0.001
Lung Infection-non-SAE, NR, Mod	0.003	0
Lung Infection-non-SAE, NR, Severe	0.003	0
Lymph Gland Infection-non-SAE, NR, Mod	0.003	0
Lymph Node Pain-non-SAE, NR, Mild	0.003	0
Lymph Node Pain-non-SAE, NR, Mod	0	0.001
Lymph Node Palpable-non-SAE, NR, Mild	0.003	0
Lymphadenitis-non-SAE, NR, Mod	0.003	0
Lymphadenopathy-non-SAE, NR, Mild	0.005	0.007
Lymphangitis-non-SAE, NR, Mod	0	0.001
Lymphocyte Count Decreased-non-SAE, RIGIV, Mild	0	0.001
Lymphoedema-non-SAE, NR, Severe	0.003	0
Malaise-non-SAE, NR, Mild	0	0.002
Malaise-non-SAE, NR, Mod	0	0.001
Malaise-non-SAE, RIGIV, Mod	0.003	0
Malaise-non-SAE, RrHu, Mild	0	0.001
Malaise-non-SAE, RrHu, Mod	0	0.001
Memory Impairment-non-SAE, NR, Mod	0	0.001
Migraine-non-SAE, NR, Mild	0.003	0.001
Migraine-non-SAE, NR, Mod	0	0.002
Migraine-non-SAE, NR, Severe	0.003	0
Migraine-non-SAE, RIGIV, Mild	0.003	0.001
Migraine-non-SAE, RIGIV, Mod	0.003	0.004
Migraine-non-SAE, RIGIV, Severe	0	0.001
Migraine-non-SAE, Rboth, Mod	0	0.001
Molluscum Contagiosum-non-SAE, NR, Mild	0.005	0
Mouth Ulceration-non-SAE, NR, Mild	0.003	0
Multiple Sclerosis Relapse-non-SAE, NR, Mod	0	0.001
Muscle Fatigue-non-SAE, NR, Mild	0	0.001
Muscle Injury-non-SAE, NR, Mild	0	0.002
Muscle Spasms-non-SAE, NR, Mild	0	0.001
Muscle Spasms-non-SAE, RIGIV, Mild	0.003	0
Muscle Strain-non-SAE, NR, Mild	0.003	0.001
Muscle Strain-non-SAE, NR, Mod	0	0.001
Muscular Weakness-non-SAE, NR, Mild	0.003	0
Musculoskeletal Chest Pain-non-SAE, NR, Mild	0	0.001
Musculoskeletal Chest Pain-non-SAE, RIGIV, Mild	0	0.001
Musculoskeletal Pain-non-SAE, NR, Mild	0.005	0
Musculoskeletal Pain-non-SAE, NR, Mod	0.003	0.001
Musculoskeletal Stiffness-non-SAE, NR, Mild	0.003	0.001
Myalgia-non-SAE, NR, Mild	0.008	0.004
Myalgia-non-SAE, NR, Mod	0.003	0.004
Myalgia-non-SAE, NR, Severe	0	0.001
Myalgia-non-SAE, RIGIV, Mild	0	0.005
Myalgia-non-SAE, RIGIV, Mod	0.003	0.001
Myalgia-non-SAE, Rboth, Mild	0	0.003

56. Secondary Outcome

Title	Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z)
Description	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
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Measure Infusions	365	1129
Nasal Congestion-non-SAE, NR, Mild	0.011	0.003
Nasal Congestion-non-SAE, NR, Mod	0	0.002
Nasal Congestion-non-SAE, RIGIV, Mild	0	0.003
Nasal Discomfort-non-SAE, NR, Mild	0	0.001
Nasal Mucosal Discolouration-non-SAE, NR, Mild	0	0.001
Nasal Turbinate Hypertrophy-non-SAE, NR, Mild	0	0.001
Nasopharyngitis-non-SAE, NR, Mild	0.011	0.007
Nausea-non-SAE, NR, Mild	0.008	0.015
Nausea-non-SAE, NR, Mod	0.005	0.003
Nausea-non-SAE, RIGIV, Mild	0.019	0.001
Nausea-non-SAE, RIGIV, Mod	0.003	0
Nausea-non-SAE, Rboth, Mild	0	0.004
Neck Pain-non-SAE, NR, Mild	0.003	0.001
Night Sweats-non-SAE, NR, Mild	0.003	0
Night Sweats-non-SAE, NR, Mod	0	0.001
Nodule-non-SAE, Rboth, Mild	0	0.002
Oedema-non-SAE, RIGIV, Mild	0	0.001
Oedema Genital-non-SAE, Rboth, Severe	0	0.001
Oedema Peripheral-non-SAE, NR, Mild	0	0.001
Oedema Peripheral-non-SAE, NR, Mod	0	0.001
Oedema Peripheral-non-SAE, Rboth, Mod	0	0.002
Oesophagitis-non-SAE, NR, Mild	0	0.001
Onychomycosis-non-SAE, NR, Mild	0	0.001
Oral Candidiasis-non-SAE, NR, Mod	0	0.001
Oral Fungal Infection-non-SAE, NR, Mild	0	0.001
Oral Herpes-non-SAE, NR, Mild	0.003	0.002
Oral Herpes-non-SAE, NR, Mod	0	0.001
Oral Pain-non-SAE, NR, Mild	0	0.001
Oral Pain-non-SAE, RrHu, Severe	0	0.001
Oropharyngeal Pain-non-SAE, NR, Mild	0.003	0.004
Oropharyngeal Pain-non-SAE, NR, Mod	0.005	0.001
Osteoarthritis-non-SAE, NR, Mod	0	0.001
Osteopenia-non-SAE, NR, Mild	0	0.001
Osteopenia-non-SAE, NR, Mod	0	0.001
Osteoporosis-non-SAE, NR, Mild	0	0.001
Otitis Externa-non-SAE, NR, Mild	0	0.001
Otitis Externa-non-SAE, NR, Mod	0	0.001
Otitis Media-non-SAE, NR, Mod	0.003	0.001
Pain-non-SAE, NR, Mild	0.003	0.004
Pain-non-SAE, NR, Mod	0.003	0.001
Pain-non-SAE, RIGIV, Mild	0	0.001
Pain-non-SAE, RIGIV, Mod	0.005	0.001
Pain-non-SAE, Rboth, Mild	0	0.001
Pain-non-SAE, Rboth, Mod	0	0.001
Pain in Extremity-non-SAE, NR, Mild	0.005	0.001
Pain in Extremity-non-SAE, NR, Mod	0.003	0.002
Pain in Extremity-non-SAE, RIGIV, Mod	0.005	0
Pain in Extremity-non-SAE, RIGIV, Severe	0.003	0
Pain in Extremity-non-SAE, Rboth, Mild	0	0.003
Pain in Extremity-non-SAE, Rboth, Mod	0	0.002
Palpitations-non-SAE, NR, Mild	0.003	0.001
Papule-non-SAE, NR, Mild	0	0.001
Peptic Ulcer Haemorrhage-SAE, NR, Severe	0.003	0
Periorbital Haematoma-non-SAE, NR, Mild	0	0.001
Peripheral Nerve Injury-non-SAE, NR, Mild	0	0.001
Pertussis-non-SAE, NR, Mod	0	0.001
Petit Mal Epilepsy-SAE, NR, Severe	0	0.001
Pharyngeal Erythema-non-SAE, NR, Mild	0.003	0.003
Pharyngitis-non-SAE, NR, Mild	0.003	0.004
Pharyngitis-non-SAE, NR, Mod	0.003	0
Pharyngitis Streptococcal-non-SAE, NR, Mod	0	0.004
Pneumonia-non-SAE, NR, Mild	0	0.001
Pneumonia-non-SAE, NR, Mod	0	0.001
Pneumonia Bacterial-non-SAE, NR, Mod	0	0.001
Post Procedural Infection-non-SAE, NR, Mild	0.003	0.002
Post Procedural Infection-non-SAE, NR, Mod	0	0.004
Postictal Paralysis-non-SAE, NR, Mod	0	0.001
Postoperative Wound Infection-non-SAE, NR, Mod	0	0.001
Procedural Pain-non-SAE, NR, Mild	0	0.002
Procedural Pain-non-SAE, NR, Mod	0	0.001
Productive Cough-non-SAE, NR, Mild	0.003	0.001
Pruritus-non-SAE, NR, Mild	0.003	0
Pruritus-non-SAE, RIGIV, Mild	0.003	0
Pruritus-non-SAE, Rboth, Mild	0	0.001
Pruritus-non-SAE, Rboth, Mod	0	0.001
Pruritus Generalized-non-SAE, NR, Mild	0.003	0
Pseudomonas Infection-non-SAE, NR, Mod	0	0.001
Psoriasis-non-SAE, NR, Mod	0	0.001
Pyrexia-non-SAE, NR, Mild	0.008	0.010
Pyrexia-non-SAE, NR, Mod	0.005	0.001
Pyrexia-non-SAE, RIGIV, Mild	0.011	0.005
Pyrexia-non-SAE, RIGIV, Mod	0.005	0.002
Pyrexia-non-SAE, Rboth, Mild	0	0.002
Rales-non-SAE, NR, Mild	0	0.001
Rales-non-SAE, NR, Mod	0	0.001
Rash-non-SAE, NR, Mild	0.005	0.004
Rash-non-SAE, NR, Mod	0	0.001
Rash Erythematous-non-SAE, NR, Mild	0	0.001
Rash Maculo-Papular-non-SAE, Rboth, Mild	0	0.001
Rash Pustular-non-SAE, NR, Mild	0	0.001
Rash Pustular-non-SAE, NR, Mod	0.003	0
Rash Papular-non-SAE, NR, Mild	0	0.001
Respiratory Failure-SAE, NR, Severe	0	0.001
Respiratory Rate Increased-non-SAE, NR, Mild	0	0.001
Respiratory Tract Congestion-non-SAE, NR, Mild	0	0.001
Respiratory Tract Infection-non-SAE, NR, Mild	0.003	0.001
Respiratory Tract Infection-non-SAE, NR, Mod	0.003	0.003
Respiratory Tract Infection Viral-non-SAE, NR, Mod	0.003	0
Rhinitis Allergic-non-SAE, NR, Mild	0.003	0.003
Rhinitis Allergic-non-SAE, NR, Mod	0.008	0.001
Rhinitis Allergic-non-SAE, RIGIV, Mod	0.003	0
Rhinorrhoea-non-SAE, NR, Mild	0.003	0.001
Road Traffic Accident-non-SAE, NR, Mod	0	0.002
Scleritis-non-SAE, NR, Mild	0.003	0.001
Scleritis-non-SAE, NR, Mod	0	0.001
Scratch-non-SAE, NR, Mild	0.003	0
Seborrhoeic Dermatitis-non-SAE, NR, Mild	0	0.001
Sicca Syndrome-non-SAE, NR, Mod	0	0.001
Sinus Congestion-non-SAE, NR, Mild	0.003	0
Sinus Headache-non-SAE, NR, Mild	0.003	0
Sinusitis-non-SAE, NR, Mild	0.016	0.022
Sinusitis-non-SAE, NR, Mod	0.036	0.023
Sinusitis-non-SAE, NR, Severe	0	0.001
Sinusitis-non-SAE, RIGIV, Mod	0	0.001
Skeletal Injury-non-SAE, NR, Mild	0	0.001
Skeletal Injury-non-SAE, NR, Mod	0	0.001
Skin Hyperpigmentation-non-SAE, Rboth, Mild	0	0.001
Skin Laceration-non-SAE, NR, Mild	0	0.001
Skin Laceration-non-SAE, NR, Mod	0	0.001
Skin Lesion-non-SAE, NR, Mild	0.005	0.001
Skin Lesion-non-SAE, NR, Mod	0.003	0
Skin Lesion-non-SAE, RIGIV, Mild	0	0.002
Skin Papilloma-non-SAE, NR, Mod	0.003	0
Spinal Osteoarthritis-non-SAE, NR, Mild	0	0.002
Squamous Cell Carcinoma-non-SAE, NR, Mod	0.003	0.001
Status Epilepticus-SAE, NR, Severe	0	0.001
Suicidal Ideation-non-SAE, NR, Mild	0.003	0
Sunburn-non-SAE, NR, Mild	0	0.001
Swelling-non-SAE, Rboth, Mild	0	0.001
Swelling-non-SAE, Rboth, Mod	0	0.003
Syncope-non-SAE, NR, Mild	0	0.001
Tachycardia-non-SAE, NR, Mild	0	0.003
Tachycardia-non-SAE, NR, Mod	0	0.001
Therapy Cessation-non-SAE, NR, Severe	0	0.001
Thrombosis-non-SAE, NR, Severe	0	0.001
Thrombosis-SAE, NR, Mod	0	0.001
Tinea Infection-non-SAE, NR, Mild	0.005	0
Tongue Coated-non-SAE, NR, Mild	0	0.001
Tonsillar Hypertrophy-non-SAE, NR, Mod	0	0.001
Tonsillar Hypertrophy-SAE, NR, Mild	0	0.001
Tooth Abscess-non-SAE, NR, Mild	0.003	0
Tooth Abscess-non-SAE, NR, Mod	0	0.001
Tooth Impacted-non-SAE, NR, Mod	0	0.001
Tooth Infection-non-SAE, NR, Mod	0	0.001
Toothache-non-SAE, NR, Mod	0	0.001
Tongue Injury-non-SAE, NR, Mild	0	0.001
Tremor-non-SAE, NR, Mild	0	0.001
Tricuspid Valve Incompetence-non-SAE, NR, Mild	0	0.001
Tympanic Membrane Disorder-non-SAE, NR, Mild	0.003	0
Tympanic Membrane Hyperaemia-non-SAE, NR, Mild	0	0.002
Upper Airway Cough Syndrome-non-SAE, NR, Mild	0	0.001
Upper Resp. Tract Infection-non-SAE, NR, Mild	0.019	0.030
Upper Resp. Tract Infection-non-SAE, NR, Mod	0.005	0.009
Urinary Tract Infection-non-SAE, NR, Mild	0.003	0.002
Urinary Tract Infection-non-SAE, NR, Mod	0.014	0.004
Urine Analysis Abnormal-non-SAE, NR, Mild	0	0.001
Urticaria-non-SAE, NR, Mild	0	0.004
Urticaria-non-SAE, NR, Mod	0	0.001
Urticaria-non-SAE, RIGIV, Mild	0.003	0
Uterine Polyp-non-SAE, NR, Mod	0	0.001
Vaginal Haemorrhage-non-SAE, NR, Mod	0	0.001
Vascular Access Complication-non-SAE, NR, Mild	0.003	0
Vertigo-non-SAE, NR, Mod	0	0.001
Viral Diarrhoea-non-SAE, NR, Mild	0	0.001
Viral Infection-non-SAE, NR, Mild	0008	0.006
Viral Infection-non-SAE, NR, Mod	0.008	0.003
Viral Infection-SAE, NR, Mild	0.003	0
Viral Upper Resp. Tract Infection-non-SAE, NR Mild	0.003	0.007
Viral Upper Resp. Tract Infection-non-SAE, NR, Mod	0.003	0.001
Vision Blurred-non-SAE, NR, Mild	0	0.001
Vitamin D Deficiency-non-SAE, NR, Mild	0.003	0
Vitamin D Deficiency-non-SAE, NR, Mod	0	0.002
Vomiting-non-SAE, NR, Mild	0.014	0.006
Vomiting-non-SAE, NR, Mod	0	0.003
Vomiting-non-SAE, RIGIV, Mild	0.011	0.003
Vomiting-non-SAE, RIGIV, Mod	0.003	0.004
Vomiting-non-SAE, RIGIV, Severe	0.003	0
Vomiting-non-SAE, Rboth, Mod	0	0.001
Vulvovaginal Pruritus-non-SAE, RIGIV, Mild	0	0.001
Weight Decreased-non-SAE, RrHu, Mild	0	0.001
Weight Decreased-non-SAE, RrHu, Mod	0	0.001
Wheezing-non-SAE, NR, Mod	0	0.001
WBC Count Decreased-non-SAE, RIGIV, Mild	0	0.001
White Blood Cells Urine Positive-non-SAE, NR, Mild	0	0.001
WBC Urine Positive-non-SAE, RIGIV Mild	0.003	0

57. Secondary Outcome

Title	Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F)
Description	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
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Abdominal Discomfort-non-SAE, NR, Mod	0	0.012
Abdominal Distension-non-SAE, Rboth, Mild	0	0.012
Abdominal Hernia-non-SAE, NR, Mild	0	0.012
Abdominal Pain-non-SAE, NR, Mild	0.011	0.025
Abdominal Pain-non-SAE, NR, Mod	0	0.012
Abdominal Pain-non-SAE, Rboth, Mild	0	0.037
Abdominal Pain-non-SAE, Rboth, Mod	0	0.012
Abdominal Pain Lower-non-SAE, NR, Mild	0	0.012
Abdominal Pain Upper-non-SAE, NR, Mild	0.011	0.062
Abdominal Pain Upper-non-SAE, NR, Mod	0.011	0
Abdominal Pain Upper-non-SAE, RIGIV, Mild	0	0.012
Abdominal Pain Upper-non-SAE, RIGIV, Mod	0.011	0
Abdominal Pain Upper-non-SAE, Rboth, Mild	0	0.025
Abdominal Tenderness-non-SAE, NR, Mod	0.011	0
Abdominal Tenderness-non-SAE, RIGIV, Mild	0	0.012
Abdominal Tenderness-non-SAE, RIGIV, Mod	0	0.025
Acarodermatitis-non-SAE, NR, Mild	0	0.012
Acne-non-SAE, NR, Mild	0.011	0.012
Acute Sinusitis-non-SAE, NR, Mild	0.011	0
Acute Sinusitis-non-SAE, NR, Mod	0	0.049
Adenoidal Hypertrophy-non-SAE, NR, Mod	0	0.012
Adnexa Uteri Cyst-non-SAE, NR, Mild	0.011	0
Adrenocortical Insufficiency Acute-SAE, NR, Mod	0	0.012
Allergic Respiratory Symptom-non-SAE, NR, Mild	0	0.012
Allergic Sinusitis-non-SAE, NR, Mild	0.011	0
Alopecia-non-SAE, NR, Mild	0.011	0
Animal Bite-non-SAE, NR, Mod	0.011	0
Antibody Test Positive-non-SAE, Rboth, Mod	0	0.012
Anxiety-non-SAE, NR, Mild	0	0.012
Anxiety-non-SAE, NR, Mod	0.011	0
Aphthous Stomatitis-non-SAE, NR, Mild	0.023	0.012
Aphthous Stomatitis-non-SAE, NR, Mod	0	0.012
Arteriosclerosis Coronary Artery-non-SAE, NR, Mild	0	0.012
Arthralgia-non-SAE, NR, Mild	0	0.062
Arthralgia-non-SAE, NR, Mod	0.011	0.074
Arthralgia-non-SAE, RIGIV, Mild	0	0.012
Arthralgia-non-SAE, RIGIV, Mod	0	0.025
Arthritis-non-SAE, NR, Mod	0.011	0.012
Arthropathy-non-SAE, NR, Mod	0.011	0
Arthropod Bite-non-SAE, NR, Mild	0.023	0.025
Arthropod Sting-non-SAE, NR, Mild	0	0.012
Arthropod Sting-non-SAE, NR, Mod	0.011	0
Aspiration-non-SAE, NR, Mild	0	0.012
Asthenia-non-SAE, NR, Mild	0	0.037
Asthenia-non-SAE, NR, Mod	0.011	0
Asthenia-non-SAE, RIGIV, Mild	0	0.012
Asthma-non-SAE, NR, Mild	0	0.049
Asthma-non-SAE, NR, Mod	0.092	0.259
Asthma-non-SAE, NR, Severe	0	0.012
ADHD-non-SAE, NR, Mod	0	0.012
Back Injury-non-SAE, NR, Mod	0.011	0
Back Injury-SAE, NR, Severe	0	0.012
Back Pain-non-SAE, NR, Mild	0.011	0.025
Back Pain-non-SAE, NR, Mod	0.011	0.062
Bacterial Prostatitis-non-SAE, NR, Mild	0	0.012
Blepharitis-non-SAE, NR, Mod	0.011	0
Blister-non-SAE, NR, Mild	0	0.012
Blood Pressure Decreased-non-SAE, NR, Mild	0	0.012
Blood Pressure Decreased-non-SAE, Rboth, Mild	0	0.012
Blood Pressure Increased-non-SAE, NR, Mod	0	0.012
Blood Pressure Increased-non-SAE, RIGIV, Mild	0	0.012
Blood Pressure Increased-non-SAE, RIGIV, Mod	0	0.012
Blood Pressure Increased-non-SAE, RrHu, Mild	0	0.012
BP Systolic Increased-non-SAE, RIGIV, Mild	0.011	0
Blood Urea Increased-non-SAE, NR, Mild	0	0.012
Body Fat Disorder-non-SAE, NR, Mild	0	0.012
Body Tinea-non-SAE, NR, Mild	0.011	0
Body Tinea-non-SAE, NR, Mod	0	0.012
Bone Pain-non-SAE, NR, Mild	0	0.012
Breast Pain-non-SAE, NR, Mild	0.011	0
Bronchal Hyperreactivity-non-SAE, NR, Mild	0	0.012
Bronchitis-non-SAE, NR, Mild	0.046	0.025
Bronchitis-non-SAE, NR, Mod	0.023	0.099
Bronchitis-SAE, NR, Mod	0.011	0
Bronchospasm-non-SAE, NR, Mod	0	0.012
Burn Infection-non-SAE, NR, Mild	0	0.012
Burning Sensation-non-SAE, RIGIV, Mild	0	0.012
Burning Sensation-non-SAE, RIGIV, Mod	0	0.012
Burning Sensation-non-SAE, RrHu, Mild	0	0.012
Bursitis-non-SAE, NR, Mild	0.011	0
Bursitis-non-SAE, NR, Mod	0	0.012
Candidiasis-non-SAE, NR, Mild	0.011	0
Candidiasis-non-SAE, NR, Mod	0.011	0.012
Cardiac Murmur-non-SAE, NR, Mild	0	0.012
Cellulitis-non-SAE, NR, Mild	0	0.012
Cellulitis-non-SAE, NR, Mod	0	0.037
Cellulitis-non-SAE, Rboth, Mod	0	0.012
Cerumen Impaction-non-SAE, NR, Mild	0	0.025
Cervical Dysplasia-SAE, NR, Mild	0.011	0.012
Cheilitis-non-SAE, NR, Mild	0.023	0
Chest Pain-non-SAE, NR, Mild	0	0.025
Chills-non-SAE, NR, Mild	0	0.037
Chills-non-SAE, RIGIV, Mild	0.069	0.012
Chills-non-SAE, RIGIV, Mod	0.034	0
Chills-non-SAE, Rboth, Mild	0	0.012
COPD-non-SAE, NR, Mod	0	0.025
COPD-non-SAE, NR, Severe	0.011	0
Chronic Sinusitis-non-SAE, NR, Mild	0	0.049
Chronic Sinusitis-non-SAE, NR, Mod	0.011	0.012
Concussion-non-SAE, NR, Mod	0.011	0
Confusional State-non-SAE, NR, Mod	0	0.012
Confusional State-non-SAE, RIGIV, Mild	0.011	0
Conjunctivitis-non-SAE, NR, Mild	0.011	0.025
Conjunctivitis Allergic-non-SAE, NR, Mild	0.011	0
Conjunctivitis Allergic-non-SAE, NR, Mod	0.011	0
Conjunctivitis Bacterial-non-SAE, NR, Mild	0.011	0.012
Conjunctivitis Bacterial-non-SAE, NR, Mod	0	0.012
Conjunctivitis Bacterial-non-SAE, NR, Severe	0	0.012
Constipation-non-SAE, NR, Mild	0	0.037
Contusion-non-SAE, NR, Mild	0.011	0.062
Contusion-non-SAE, NR, Mod	0.011	0
Contusion-non-SAE, RIGIV, Mod	0	0.012
Coombs Test Positive-non-SAE, RIGIV, Mild	0	0.012
Costochondritis-non-SAE, NR, Mod	0	0.012
Cough-non-SAE, NR, Mild	0.034	0.074
Cough-non-SAE, NR, Mod	0	0.025
Cough-non-SAE, RIGIV, Mild	0.011	0
Cushingoid-non-SAE, NR, Mild	0	0.012
Cystitis-non-SAE, NR, Mild	0	0.012
Deafness Neurosensory-non-SAE, NR, Mild	0.011	0
Decreased Appetite-non-SAE, NR, Mild	0.011	0.012
Decreased Appetite-non-SAE, RrHu, Mild	0	0.012
Decreased Appetite-non-SAE, Rboth, Mild	0	0.025
Dehydration-non-SAE, NR, Mod	0	0.025
Dental Caries-non-SAE, NR, Mild	0	0.025
Dental Caries-non-SAE, NR, Mod	0	0.037
Depressed Mood-non-SAE, NR, Mild	0	0.012
Depression-non-SAE, NR, Severe	0	0.012
Dermal Cyst-non-SAE, NR, Mild	0	0.012
Dermatitis-non-SAE, NR, Mild	0	0.025
Dermatitis-non-SAE, NR, Mod	0.011	0
Dermatitis Acneiform-non-SAE, NR, Mod	0.011	0
Dermatitis Contact-non-SAE, NR, Mild	0	0.025
Dermatitis Contact-non-SAE, NR, Mod	0.023	0.025
Dermatitis Infected-non-SAE, NR, Mild	0	0.025
Dermatitis Infected-non-SAE, NR, Mod	0	0.012
Dermatitis Infected-non-SAE, NR, Severe	0	0.012
Device Failure-non-SAE, NR, Mild	0.023	0.012
Device Failure-non-SAE, NR, Mod	0	0.025
Diarrhoea-non-SAE, NR, Mild	0.034	0.074
Diarrhoea-non-SAE, NR, Mod	0.023	0.049
Diarrhoea-non-SAE, RIGIV, Mild	0.011	0.012
Diarrhoea-non-SAE, RIGIV, Mod	0.011	0
Diarrhoea Haemorrhagic-non-SAE, NR, Mild	0.011	0
Diarrhoea Infectious-non-SAE, NR, Mild	0	0.012
Diastolic Dysfunction-non-SAE, NR, Mild	0	0.012
Disaccharide Metabolism Disorder-non-SAE, NR, Mild	0	0.012
Disturbance in Attention-non-SAE, NR, Mild	0	0.025
Diverticulitis-non-SAE, NR, Mod	0.011	0
Dizziness-non-SAE, NR, Mild	0.023	0.086
Dizziness-non-SAE, NR, Mod	0	0.025
Dizziness-non-SAE, RIGIV, Mild	0	0.037
Dizziness-non-SAE, RIGIV, Mod	0.011	0
Drug Eruption-non-SAE, NR, Mod	0.011	0
Dry Eye-non-SAE, NR, Mod	0	0.012
Dry Mouth-non-SAE, NR, Mild	0	0.012
Dry Skin-non-SAE, NR, Mild	0	0.037
Dysmenorrhoea-non-SAE, NR, Mild	0	0.012
Dyspepsia-non-SAE, NR, Mild	0	0.025
Dyspepsia-non-SAE, NR, Mod	0	0.012
Dyspepsia-non-SAE, RIGIV, Mild	0.011	0
Dysphagia-non-SAE, NR, Mild	0	0.012
Dysphagia-non-SAE, NR, Mod	0	0.012
Dyspnoea-non-SAE, NR, Mild	0.011	0
Dyspnoea-non-SAE, NR, Mod	0.011	0
Dyspnoea-non-SAE, RIGIV, Mild	0.011	0
Dysuria-non-SAE, NR, Mild	0	0.025
Ear Infection-non-SAE, NR, Mild	0.023	0.025
Ear Infection-non-SAE, NR, Mod	0.011	0.012
Ear Pain-non-SAE, NR, Mild	0.034	0.025
Ear Pain-non-SAE, NR, Mod	0	0.012
Ecchymosis-non-SAE, NR, Mild	0	0.012
Eczema-non-SAE, NR, Mild	0	0.012
Eczema-non-SAE, NR, Mod	0	0.012
Eczema-non-SAE, NR, Severe	0.011	0
Eosinophil Count-non-SAE, NR, Mild	0	0.012
Epitaxis-non-SAE, NR, Mild	0.023	0.037
Epitaxis-non-SAE, NR, Mod	0.023	0.025
Erythema-non-SAE, NR, Mild	0.011	0
Erythema-non-SAE, RIGIV, Mod	0	0.012
Erythema-non-SAE, RrHu, Mild	0	0.012
Erythema-non-SAE, Rboth, Mild	0	0.012
Erythema-non-SAE, Rboth, Mod	0	0.012
Eustachian Tube Dysfunction-non-SAE, NR, Mild	0.011	0
Excoriation-non-SAE, NR, Mild	0.025	0.025
Extravasation Blood-non-SAE, Rboth, Mild	0	0.012
Eye Irritation-non-SAE, NR, Mild	0	0.012
Eye Pruritus-non-SAE, NR, Mod	0	0.012
Eye Swelling-non-SAE, NR, Mod	0	0.012
Fall-non-SAE, NR, Mild	0	0.012
Fall-non-SAE, NR, Mod	0	0.012
Fatigue-non-SAE, NR, Mild	0.011	0.062
Fatigue-non-SAE, NR, Mod	0.011	0.025
Fatigue-non-SAE, RIGIV, Mild	0.092	0.099
Fatigue-non-SAE, RIGIV, Mod	0	0.037
Fatigue-non-SAE, Rboth, Mild	0	0.037
Feeling Abnormal-non-SAE, Rboth, Mod	0	0.012
Feeling Cold-non-SAE, RIGIV, Mild	0.023	0
Flatulence-non-SAE, NR, Mild	0	0.012
Flatulence-non-SAE, NR, Mod	0	0.012
Food Poisoning-non-SAE, NR, Mod	0	0.012
Free Haemoglobin Present-non-SAE, NR, Mild	0.011	0.012
Free Haemoglobin Present-non-SAE, NR, Severe	0.011	0

58. Secondary Outcome

Title	Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M)
Description	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
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Gait Disturbance-non-SAE, NR, Mild	0	0.012
Gastroenteritis-non-SAE, NR, Mild	0	0.037
Gastroenteritis-non-SAE, NR, Mod	0.023	0.025
Gastroenteritis-non-SAE, RIGIV, Mild	0.011	0
Gastroenteritis-SAE, NR, Mod	0	0.012
Gastroenteritis Bacterial-non-SAE, NR, Mod	0	0.012
Gastroenteritis Viral-non-SAE, NR, Mild	0.034	0.074
Gastroenteritis Viral-non-SAE, NR, Mod	0	0.062
Gastroenteritis Viral-non-SAE, RIGIV, Mild	0	0.012
Gastrointestinal Haemorrhage-non-SAE, NR, Severe	0	0.012
Gastrooesophageal Reflux Disease-non-SAE, NR, Mild	0.011	0.025
Gastrooesophageal Reflux Disease-non-SAE, NR, Mod	0.011	0
Genital Herpes-non-SAE, NR, Mild	0.011	0
Genital Swelling-non-SAE, Rboth, Mod	0	0.012
Goitre-non-SAE, NR, Mild	0.011	0
Gout-non-SAE, NR, Mild	0	0.012
Grand Mal Convulsion-non-SAE, NR, Severe	0.011	0
Grand Mal Convulsion-SAE, NR, Severe	0	0.012
Gravitational Oedema-non-SAE, Rboth, Mod	0	0.012
Groin Pain-non-SAE, NR, Mild	0	0.012
Groin Pain-non-SAE, RIGIV, Mild	0	0.012
Groin Pain-non-SAE, RrHu, Mod	0	0.012
Haematoma-non-SAE, NR, Mild	0.011	0.012
Haematoma-non-SAE, NR, Mod	0	0.012
Haematuria-non-SAE, NR, Mild	0	0.012
Haemoglobin Abnormal-non-SAE, NR, Mild	0	0.012
Haemorrhoids-non-SAE, NR, Mild	0	0.025
Hand Fracture-non-SAE, NR, Mod	0	0.012
Headache-non-SAE, NR, Mild	0.149	0.198
Headache-non-SAE, NR, Mod	0.011	0.037
Headache-non-SAE, NR, Severe	0.011	0
Headache-non-SAE, RIGIV, Mild	0.287	0.173
Headache-non-SAE, RIGIV, Mod	0.138	0.062
Headache-non-SAE, RIGIV, Severe	0.011	0
Headache-non-SAE, Rboth, Mild	0	0.011
Headache-non-SAE, Rboth, Mod	0	0.099
Headache-SAE, NR, Severe	0	0.012
Hearing Impaired-non-SAE, NR, Mild	0	0.012
Heart Rate Increased-non-SAE, RIGIV, Mild	0.046	0
Heat Rash-non-SAE, NR, Mild	0	0.012
Heat Stroke-non-SAE, NR, Mod	0	0.012
Herpes Simplex Ophthalmic-non-SAE, NR, Mod	0	0.012
Herpes Zoster-non-SAE, NR, Mod	0	0.012
Hiatus Hernia-non-SAE, NR, Mod	0	0.012
Hot Flush-non-SAE, RIGIV, Mild	0.011	0
Hyperaesthesia-non-SAE, NR, Mild	0	0.012
Hypercholesterolaemia-non-SAE, NR, Mod	0	0.012
Hyperkeratosis-non-SAE, NR, Mild	0	0.012
Hypertension-non-SAE, NR, Mod	0	0.049
Hypertension-non-SAE, RIGIV, Mild	0	0.025
Hypertension-non-SAE, RIGIV, Mod	0	0.012
Hypertonia-non-SAE, NR, Mild	0	0.012
Hypothyroidism-non-SAE, NR, Mild	0	0.012
Idiopathic Urticaria-non-SAE, NR, Mod	0.011	0
Increased Upper Airway Secretion-non-SAE, NR, Mild	0.023	0
Infected Bites-non-SAE, NR, Mild	0	0.025
Infected Bites-non-SAE, NR, Mod	0.011	0.012
Infection-non-SAE, NR, Mod	0	0.025
Influenza-non-SAE, NR, Mild	0.011	0.025
Influenza-non-SAE, NR, Mod	0.046	0.037
Influenza Like Illness-non-SAE, NR, Mild	0	0.012
Infusion Related Reaction-non-SAE, RIGIV, Mild	0	0.012
Infusion Related Reaction-non-SAE, RIGIV, Mod	0.011	0
Infusion Related Reaction-non-SAE, Rboth, Mild	0	0.012
Infusion Related Reaction-non-SAE, Rboth, Mod	0	0.012
Infusion Site Discomfort-non-SAE, RIGIV, Mild	0	0.074
Infusion Site Discomfort-non-SAE, RrHu, Mod	0	0.012
Infusion Site Discomfort-non-SAE, Rboth, Mild	0	0.185
Infusion Site Discomfort-non-SAE, Rboth, Mod	0	0.099
Infusion Site Erythema-non-SAE, RIGIV, Mild	0	0.012
Infusion Site Erythema-non-SAE, RrHu, Mild	0	0.025
Infusion Site Erythema-non-SAE, Rboth, Mild	0	0.247
Infusion Site Erythema-non-SAE, Rboth, Mod	0	0.062
Infusion Site Extravasation-non-SAE, NR, Mild	0.023	0
Infusion Site Haematoma-non-SAE, RIGIV, Mild	0	0.012
Infusion Site Haemorrhage-non-SAE, Rboth, Mild	0	0.012
Infusion Site Hypersensitivity-non-SAE, NR, Severe	0	0.012
Infusion Site Hypersensitivity-non-SAE, Rboth, Mod	0	0.012
Infusion Site Mass-non-SAE, RIGIV, Mild	0	0.012
Infusion Site Mass-non-SAE, Rboth, Mild	0	0.025
Infusion Site Oedema-non-SAE, Rboth, Mild	0	0.049
Infusion Site Oedema-non-SAE, Rboth, Mod	0	0.062
Infusion Site Pain-non-SAE, NR, Mild	0	0.025
Infusion Site Pain-non-SAE, RIGIV, Mild	0.011	0.148
Infusion Site Pain-non-SAE, RIGIV, Mod	0	0.074
Infusion Site Pain-non-SAE, RrHu, Mild	0	0.432
Infusion Site Pain-non-SAE, RrHu, Mod	0	0.012
Infusion Site Pain-non-SAE, Rboth, Mild	0	0.235
Infusion Site Pain-non-SAE, Rboth, Mod	0	0.198
Infusion Site Pain-non-SAE, Rboth, Severe	0	0.012
Infusion Site Pruritus-non-SAE, RIGIV, Mild	0	0.025
Infusion Site Pruritus-non-SAE, RrHu, Mild	0	0.062
Infusion Site Pruritus-non-SAE, Rboth, Mild	0	0.074
Infusion Site Pruritus-non-SAE, Rboth, Mod	0	0.049
Infusion Site Reaction-non-SAE, Rboth, Mild	0	0.012
Infusion Site Reaction-non-SAE, Rboth, Mod	0	0.025
Infusion Site Swelling-non-SAE, RIGIV, Mild	0	0.025
Infusion Site Swelling-non-SAE, Rboth, Mild	0	0.037
Infusion Site Swelling-non-SAE, Rboth, Mod	0	0.049
Infusion Site Swelling-non-SAE, Rboth, Severe	0	0.012
Infusion Site Warmth-non-SAE, Rboth, Mild	0	0.025
Ingrowing Nail-non-SAE, NR, Mod	0	0.012
Injection Site Erythema-non-SAE, RIGIV, Mild	0	0.012
Injury-non-SAE, NR, Mild	0.011	0
Insomnia-non-SAE, NR, Mild	0.011	0
Intervertebral Disc Protrusion-non-SAE, NR, Mod	0.011	0
Irritable Bowel Syndrome-non-SAE, NR, Mild	0	0.012
Irritable Bowel Syndrome-non-SAE, NR, Mod	0	0.025
Joint Effusion-non-SAE, NR, Mild	0	0.012
Joint Effusion-non-SAE, NR, Mod	0	0.012
Joint Injury-non-SAE, NR, Mod	0.011	0.012
Joint Range of Motion Decreased-non-SAE, NR, Mod	0	0.025
Joint Sprain-non-SAE, NR, Mild	0	0.012
Joint Sprain-non-SAE, NR, Mod	0	0.025
Joint Swelling-non-SAE, NR, Mild	0	0.012
Jugular Vein Distension-non-SAE, NR, Mild	0	0.012
Lethargy-non-SAE, NR, Mild	0	0.012
Lethargy-non-SAE, RIGIV, Mod	0	0.011
Ligament Injury-non-SAE, NR, Mod	0	0.012
Ligament Sprain-non-SAE, NR, Mod	0	0.012
Limb Injury-non-SAE, NR, Mild	0.011	0
Lip Injury-non-SAE, NR, Mild	0	0.012
Lip Ulceration-non-SAE, NR, Mild	0	0.012
Local Swelling-non-SAE, RIGIV, Mild	0	0.037
Local Swelling-non-SAE, Rboth, Mild	0	0.037
Localised Infection-non-SAE, NR, Mild	0	0.012
Localised Oedema-non-SAE, RIGIV, Mild	0	0.012
Localised Oedema-non-SAE, Rboth, Mod	0	0.012
Lung Infection-non-SAE, NR, Mod	0.011	0
Lung Infection-non-SAE, NR, Severe	0.011	0
Lymph Gland Infection-non-SAE, NR, Mod	0.011	0
Lymph Node Pain-non-SAE, NR, Mild	0.011	0
Lymph Node Pain-non-SAE, NR, Mod	0	0.012
Lymph Node Palpable-non-SAE, NR, Mild	0.011	0
Lymphadenitis-non-SAE, NR, Mod	0.011	0
Lymphadenopathy-non-SAE, NR, Mild	0.023	0.099
Lymphangitis-non-SAE, NR, Mod	0	0.012
Lymphocyte Count Decreased-non-SAE, RIGIV, Mild	0	0.012
Lymphoedema-non-SAE, NR, Severe	0.011	0
Malaise-non-SAE, NR, Mild	0	0.025
Malaise-non-SAE, NR, Mod	0	0.012
Malaise-non-SAE, RIGIV, Mod	0.011	0
Malaise-non-SAE, RrHu, Mild	0	0.012
Malaise-non-SAE, RrHu, Mod	0	0.012
Memory Impairment-non-SAE, NR, Mod	0	0.012
Migraine-non-SAE, NR, Mild	0.011	0.012
Migraine-non-SAE, NR, Mod	0	0.025
Migraine-non-SAE, NR, Severe	0.011	0
Migraine-non-SAE, RIGIV, Mild	0.011	0.012
Migraine-non-SAE, RIGIV, Mod	0.011	0.049
Migraine-non-SAE, RIGIV, Severe	0	0.012
Migraine-non-SAE, Rboth, Mod	0	0.012
Molluscum Contagiosum-non-SAE, NR, Mild	0.023	0
Mouth Ulceration-non-SAE, NR, Mild	0.011	0
Multiple Sclerosis Relapse-non-SAE, NR, Mod	0	0.012
Muscle Fatigue-non-SAE, NR, Mild	0	0.012
Muscle Injury-non-SAE, NR, Mild	0	0.025
Muscle Spasms-non-SAE, NR, Mild	0	0.012
Muscle Spasms-non-SAE, RIGIV, Mild	0.011	0
Muscle Strain-non-SAE, NR, Mild	0.011	0.012
Muscle Strain-non-SAE, NR, Mod	0	0.012
Muscular Weakness-non-SAE, NR, Mild	0.011	0
Musculoskeletal Chest Pain-non-SAE, NR, Mild	0	0.012
Musculoskeletal Chest Pain-non-SAE, RIGIV, Mild	0	0.012
Musculoskeletal Pain-non-SAE, NR, Mild	0.023	0
Musculoskeletal Pain-non-SAE, NR, Mod	0.011	0.012
Musculoskeletal Stiffness-non-SAE, NR, Mild	0.011	0.012
Myalgia-non-SAE, NR, Mild	0.034	0.062
Myalgia-non-SAE, NR, Mod	0.011	0.049
Myalgia-non-SAE, NR, Severe	0	0.012
Myalgia-non-SAE, RIGIV, Mild	0	0.074
Myalgia-non-SAE, RIGIV, Mod	0.011	0.012
Myalgia-non-SAE, Rboth, Mild	0	0.037

59. Secondary Outcome

Title	Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z)
Description	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
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Nasal Congestion-non-SAE, NR, Mild	0.046	0.037
Nasal Congestion-non-SAE, NR, Mod	0	0.025
Nasal Congestion-non-SAE, RIGIV, Mild	0	0.037
Nasal Discomfort-non-SAE, NR, Mild	0	0.012
Nasal Mucosal Discolouration-non-SAE, NR, Mild	0	0.012
Nasal Turbinate Hypertrophy-non-SAE, NR, Mild	0	0.012
Nasopharyngitis-non-SAE, NR, Mild	0.046	0.099
Nausea-non-SAE, NR, Mild	0.034	0.210
Nausea-non-SAE, NR, Mod	0.023	0.037
Nausea-non-SAE, RIGIV, Mild	0.080	0.012
Nausea-non-SAE, RIGIV, Mod	0.011	0
Nausea-non-SAE, Rboth, Mild	0	0.049
Neck Pain-non-SAE, NR, Mild	0.011	0.012
Night Sweats-non-SAE, NR, Mild	0.011	0
Night Sweats-non-SAE, NR, Mod	0	0.012
Nodule-non-SAE, Rboth, Mild	0	0.025
Oedema-non-SAE, RIGIV, Mild	0	0.012
Oedema Genital-non-SAE, Rboth, Severe	0	0.012
Oedema Peripheral-non-SAE, NR, Mild	0	0.012
Oedema Peripheral-non-SAE, NR, Mod	0	0.012
Oedema Peripheral-non-SAE, Rboth, Mod	0	0.025
Oesophagitis-non-SAE, NR, Mild	0	0.012
Onychomycosis-non-SAE, NR, Mild	0	0.012
Oral Candidiasis-non-SAE, NR, Mod	0	0.012
Oral Fungal Infection-non-SAE, NR, Mild	0	0.012
Oral Herpes-non-SAE, NR, Mild	0.011	0.025
Oral Herpes-non-SAE, NR, Mod	0	0.012
Oral Pain-non-SAE, NR, Mild	0	0.012
Oral Pain-non-SAE, RrHu, Severe	0	0.012
Oropharyngeal Pain-non-SAE, NR, Mild	0.011	0.049
Oropharyngeal Pain-non-SAE, NR, Mod	0.023	0.012
Osteoarthritis-non-SAE, NR, Mod	0	0.012
Osteopenia-non-SAE, NR, Mild	0	0.012
Osteopenia-non-SAE, NR, Mod	0	0.012
Osteoporosis-non-SAE, NR, Mild	0	0.012
Otitis Externa-non-SAE, NR, Mild	0	0.012
Otitis Externa-non-SAE, NR, Mod	0	0.012
Otitis Media-non-SAE, NR, Mod	0.011	0.012
Pain-non-SAE, NR, Mild	0.011	0.062
Pain-non-SAE, NR, Mod	0.011	0.012
Pain-non-SAE, RIGIV, Mild	0	0.012
Pain-non-SAE, RIGIV, Mod	0.023	0.012
Pain-non-SAE, Rboth, Mild	0	0.012
Pain-non-SAE, Rboth, Mod	0	0.012
Pain in Extremity-non-SAE, NR, Mild	0.023	0.012
Pain in Extremity-non-SAE, NR, Mod	0.011	0.025
Pain in Extremity-non-SAE, RIGIV, Mod	0.023	0
Pain in Extremity-non-SAE, RIGIV, Severe	0.011	0
Pain in Extremity-non-SAE, Rboth, Mild	0	0.037
Pain in Extremity-non-SAE, Rboth, Mod	0	0.025
Palpitations-non-SAE, NR, Mild	0.011	0.012
Papule-non-SAE, NR, Mild	0	0.012
Peptic Ulcer Haemorrhage-SAE, NR, Severe	0.011	0
Periorbital Haematoma-non-SAE, NR, Mild	0	0.012
Peripheral Nerve Injury-non-SAE, NR, Mild	0	0.012
Pertussis-non-SAE, NR, Mod	0	0.012
Petit Mal Epilepsy-SAE, NR, Severe	0	0.012
Pharyngeal Erythema-non-SAE, NR, Mild	0.011	0.037
Pharyngitis-non-SAE, NR, Mild	0.011	0.049
Pharyngitis-non-SAE, NR, Mod	0.011	0
Pharyngitis Streptococcal-non-SAE, NR, Mod	0	0.049
Pneumonia-non-SAE, NR, Mild	0	0.012
Pneumonia-non-SAE, NR, Mod	0	0.012
Pneumonia Bacterial-non-SAE, NR, Mod	0	0.012
Post Procedural Infection-non-SAE, NR, Mild	0.011	0.025
Post Procedural Infection-non-SAE, NR, Mod	0	0.062
Postictal Paralysis-non-SAE, NR, Mod	0	0.012
Postoperative Wound Infection-non-SAE, NR, Mod	0	0.012
Procedural Pain-non-SAE, NR, Mild	0	0.025
Procedural Pain-non-SAE, NR, Mod	0	0.012
Productive Cough-non-SAE, NR, Mild	0.011	0.012
Pruritus-non-SAE, NR, Mild	0.011	0
Pruritus-non-SAE, RIGIV, Mild	0.011	0
Pruritus-non-SAE, Rboth, Mild	0	0.012
Pruritus-non-SAE, Rboth, Mod	0	0.012
Pruritus Generalized-non-SAE, NR, Mild	0.011	0
Pseudomonas Infection-non-SAE, NR, Mod	0	0.012
Psoriasis-non-SAE, NR, Mod	0	0.012
Pyrexia-non-SAE, NR, Mild	0.034	0.136
Pyrexia-non-SAE, NR, Mod	0.023	0.012
Pyrexia-non-SAE, RIGIV, Mild	0.046	0.074
Pyrexia-non-SAE, RIGIV, Mod	0.023	0.025
Pyrexia-non-SAE, Rboth, Mild	0	0.025
Rales-non-SAE, NR, Mild	0	0.012
Rales-non-SAE, NR, Mod	0	0.012
Rash-non-SAE, NR, Mild	0.023	0.062
Rash-non-SAE, NR, Mod	0	0.012
Rash Erythematous-non-SAE, NR, Mild	0	0.012
Rash Maculo-Papular-non-SAE, Rboth, Mild	0	0.012
Rash Pustular-non-SAE, NR, Mild	0	0.012
Rash Pustular-non-SAE, NR, Mod	0.011	0
Rash Papular-non-SAE, NR, Mild	0	0.012
Respiratory Failure-SAE, NR, Severe	0	0.012
Respiratory Rate Increased-non-SAE, NR, Mild	0	0.012
Respiratory Tract Congestion-non-SAE, NR, Mild	0	0.012
Respiratory Tract Infection-non-SAE, NR, Mild	0.011	0.012
Respiratory Tract Infection-non-SAE, NR, Mod	0.011	0.037
Respiratory Tract Infection Viral-non-SAE, NR, Mod	0.011	0
Rhinitis Allergic-non-SAE, NR, Mild	0.011	0.037
Rhinitis Allergic-non-SAE, NR, Mod	0.034	0.012
Rhinitis Allergic-non-SAE, RIGIV, Mod	0.011	0
Rhinorrhoea-non-SAE, NR, Mild	0.011	0.012
Road Traffic Accident-non-SAE, NR, Mod	0	0.025
Scleritis-non-SAE, NR, Mild	0.011	0.012
Scleritis-non-SAE, NR, Mod	0	0.012
Scratch-non-SAE, NR, Mild	0.011	0
Seborrhoeic Dermatitis-non-SAE, NR, Mild	0	0.012
Sicca Syndrome-non-SAE, NR, Mod	0	0.012
Sinus Congestion-non-SAE, NR, Mild	0.011	0
Sinus Headache-non-SAE, NR, Mild	0.011	0
Sinusitis-non-SAE, NR, Mild	0.069	0.309
Sinusitis-non-SAE, NR, Mod	0.149	0.321
Sinusitis-non-SAE, NR, Severe	0	0.012
Sinusitis-non-SAE, RIGIV, Mod	0	0.012
Skeletal Injury-non-SAE, NR, Mild	0	0.012
Skeletal Injury-non-SAE, NR, Mod	0	0.012
Skin Hyperpigmentation-non-SAE, Rboth, Mild	0	0.012
Skin Laceration-non-SAE, NR, Mild	0	0.012
Skin Laceration-non-SAE, NR, Mod	0	0.012
Skin Lesion-non-SAE, NR, Mild	0.023	0.012
Skin Lesion-non-SAE, NR, Mod	0.011	0
Skin Lesion-non-SAE, RIGIV, Mild	0	0.025
Skin Papilloma-non-SAE, NR, Mod	0.011	0
Spinal Osteoarthritis-non-SAE, NR, Mild	0	0.025
Squamous Cell Carcinoma-non-SAE, NR, Mod	0.011	0.012
Status Epilepticus-SAE, NR, Severe	0	0.012
Suicidal Ideation-non-SAE, NR, Mild	0.011	0
Sunburn-non-SAE, NR, Mild	0	0.012
Swelling-non-SAE, Rboth, Mild	0	0.012
Swelling-non-SAE, Rboth, Mod	0	0.037
Syncope-non-SAE, NR, Mild	0	0.012
Tachycardia-non-SAE, NR, Mild	0.037	0
Tachycardia-non-SAE, NR, Mod	0	0.012
Therapy Cessation-non-SAE, NR, Severe	0	0.012
Thrombosis-non-SAE, NR, Severe	0	0.012
Thrombosis-SAE, NR, Mod	0	0.012
Tinea Infection-non-SAE, NR, Mild	0	0.023
Tongue Coated-non-SAE, NR, Mild	0	0.012
Tonsillar Hypertrophy-non-SAE, NR, Mod	0	0.012
Tonsillar Hypertrophy-SAE, NR, Mild	0	0.012
Tooth Abscess-non-SAE, NR, Mild	0.011	0
Tooth Abscess-non-SAE, NR, Mod	0	0.012
Tooth Impacted-non-SAE, NR, Mod	0	0.012
Tooth Infection-non-SAE, NR, Mod	0	0.012
Toothache-non-SAE, NR, Mod	0	0.012
Tongue Injury-non-SAE, NR, Mild	0	0.012
Tremor-non-SAE, NR, Mild	0	0.012
Tricuspid Valve Incompetence-non-SAE, NR, Mild	0	0.012
Tympanic Membrane Disorder-non-SAE, NR, Mild	0.011	0
Tympanic Membrane Hyperaemia-non-SAE, NR, Mild	0	0.025
Upper Airway Cough Syndrome-non-SAE, NR, Mild	0	0.012
Upper Resp. Tract Infection-non-SAE, NR, Mild	0.080	0.420
Upper Resp. Tract Infection-non-SAE, NR, Mod	0.023	0.123
Urinary Tract Infection-non-SAE, NR, Mild	0.011	0.025
Urinary Tract Infection-non-SAE, NR, Mod	0.057	0.049
Urine Analysis Abnormal-non-SAE, NR, Mild	0	0.012
Urticaria-non-SAE, NR, Mild	0	0.062
Urticaria-non-SAE, NR, Mod	0	0.012
Urticaria-non-SAE, RIGIV, Mild	0.011	0
Uterine Polyp-non-SAE, NR, Mod	0	0.012
Vaginal Haemorrhage-non-SAE, NR, Mod	0	0.012
Vascular Access Complication-non-SAE, NR, Mild	0.011	0
Vertigo-non-SAE, NR, Mod	0	0.012
Viral Diarrhoea-non-SAE, NR, Mild	0	0.012
Viral Infection-non-SAE, NR, Mild	0.034	0.086
Viral Infection-non-SAE, NR, Mod	0.034	0.037
Viral Infection-SAE, NR, Mild	0.011	0
Viral Upper Resp. Tract Infection-non-SAE, NR Mild	0.011	0.099
Viral Upper Resp. Tract Infection-non-SAE, NR, Mod	0.011	0.012
Vision Blurred-non-SAE, NR, Mild	0	0.012
Vitamin D Deficiency-non-SAE, NR, Mild	0.011	0
Vitamin D Deficiency-non-SAE, NR, Mod	0	0.025
Vomiting-non-SAE, NR, Mild	0.057	0.096
Vomiting-non-SAE, NR, Mod	0	0.037
Vomiting-non-SAE, RIGIV, Mild	0.046	0.037
Vomiting-non-SAE, RIGIV, Mod	0.011	0.049
Vomiting-non-SAE, RIGIV, Severe	0.011	0
Vomiting-non-SAE, Rboth, Mod	0	0.012
Vulvovaginal Pruritus-non-SAE, RIGIV, Mild	0	0.012
Weight Decreased-non-SAE, RrHu, Mild	0	0.012
Weight Decreased-non-SAE, RrHu, Mod	0	0.012
Wheezing-non-SAE, NR, Mod	0	0.012
WBC Count Decreased-non-SAE, RIGIV, Mild	0	0.012
White Blood Cells Urine Positive-non-SAE, NR, Mild	0	0.012
WBC Urine Positive-non-SAE, RIGIV Mild	0.011	0

60. Secondary Outcome

Title	Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs
Description	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.
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 With Ramp-up
Arm/Group Description
Measure Participants	87	81
Measure Infusions	365	1129
Including infections	0.0	8.3
Excluding infections	0.0	8.3

61. Secondary Outcome

Title	Percentage of Infusions Tolerated With IV and SC Administration at Dose Used in Study Epoch 2 (SC/rHuPH20 Treatment)
Description	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.
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Measure Infusions	365	1129
Median (95% Confidence Interval) [Percentage of infusions]	100.0	100.0

62. Secondary Outcome

Title	Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion
Description	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.
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IV Administration of IGIV, 10%	SC Administration of IGIV, 10% With rHuPH20 After Ramp-up
Arm/Group Description
Measure Participants	87	81
Measure Infusions	365	1129
Including Infections	0.25	0.22
Excluding Infections	0.25	0.18

63. Secondary Outcome

Title	Number of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	87
Number [Number of participants]	0 0%

64. Secondary Outcome

Title	Percentage of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	SC Administration of IGIV, 10% With rHuPH20
Arm/Group Description
Measure Participants	81
Number [Percentage of participants]	0.0 0%

65. Secondary Outcome

Title	Number of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis
Description	Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants in Safety Data Analysis Set
Arm/Group Description	Participants exposed to either or both study drugs
Measure Participants	87
Number [Number of participants]	0 0%

66. Secondary Outcome

Title	Percentage of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis
Description	Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis
Time Frame	Throughout the study period (17 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants in Safety Data Analysis Set
Arm/Group Description	Participants exposed to either or both study drugs
Measure Participants	87
Number [Percentage of participants]	0 0%

Adverse Events

Arm/Group Title	IV Administration of IGIV, 10%		SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up)
Arm/Group Description	Consists of Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of IV infusions of immune globulin intravenous (IGIV), 10%.		Consists of participants treated SC with IGIV, 10% at 108% of IV dose during administration of IGIV, 10%. This arm INCLUDES participants during ramp-up. Ramp-up: Participants were treated with SC infusions of IGIV, 10% with recombinant human hyaluronidase (rHuPH20). Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC. During SC administration of IGIV, 10% with rHuPh20, aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV.
All Cause Mortality
	IV Administration of IGIV, 10%		SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	IV Administration of IGIV, 10%		SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/87 (3.4%)		12/83 (14.5%)
Endocrine disorders
Adrenocortical Insufficiency Acute	0/87 (0%)	0	1/83 (1.2%)	1
Gastrointestinal disorders
Peptic Ulcer Haemorrhage	1/87 (1.1%)	1	0/83 (0%)	0
Leukoplakia Oral	0/87 (0%)	0	1/83 (1.2%)	1
Infections and infestations
Bronchitis	1/87 (1.1%)	1	0/83 (0%)	0
Gastroenteritis	0/87 (0%)	0	1/83 (1.2%)	1
Viral Infection	1/87 (1.1%)	1	0/83 (0%)	0
Localised Infection	0/87 (0%)	0	1/83 (1.2%)	1
Pneumonia	0/87 (0%)	0	1/83 (1.2%)	1
Injury, poisoning and procedural complications
Back Injury	0/87 (0%)	0	1/83 (1.2%)	1
Nervous system disorders
Grand Mal Convulsion	0/87 (0%)	0	1/83 (1.2%)	1
Headache	0/87 (0%)	0	1/83 (1.2%)	1
Petit Mal Epilepsy	0/87 (0%)	0	1/83 (1.2%)	1
Status Epilepticus	0/87 (0%)	0	1/83 (1.2%)	1
Reproductive system and breast disorders
Cervical Dysplasia	1/87 (1.1%)	1	1/83 (1.2%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory Failure	0/87 (0%)	0	1/83 (1.2%)	1
Tonsillar Hypertrophy	0/87 (0%)	0	1/83 (1.2%)	1
Vascular disorders
Thrombosis	0/87 (0%)	0	1/83 (1.2%)	1
Other (Not Including Serious) Adverse Events
	IV Administration of IGIV, 10%		SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	67/87 (77%)		81/83 (97.6%)
Blood and lymphatic system disorders
LYMPHADENOPATHY	2/87 (2.3%)	2	7/83 (8.4%)	9
Gastrointestinal disorders
ABDOMINAL PAIN	1/87 (1.1%)	1	7/83 (8.4%)	10
ABDOMINAL PAIN UPPER	3/87 (3.4%)	3	6/83 (7.2%)	11
DIARRHOEA	7/87 (8%)	7	10/83 (12%)	15
NAUSEA	12/87 (13.8%)	13	15/83 (18.1%)	28
VOMITING	8/87 (9.2%)	11	13/83 (15.7%)	21
General disorders
CHILLS	7/87 (8%)	9	2/83 (2.4%)	6
FATIGUE	8/87 (9.2%)	10	14/83 (16.9%)	25
INFUSION SITE DISCOMFORT	0/87 (0%)	0	10/83 (12%)	33
INFUSION SITE ERYTHEMA	0/87 (0%)	0	14/83 (16.9%)	47
INFUSION SITE OEDEMA	0/87 (0%)	0	6/83 (7.2%)	16
INFUSION SITE PAIN	1/87 (1.1%)	1	37/83 (44.6%)	129
INFUSION SITE PRURITUS	0/87 (0%)	0	6/83 (7.2%)	21
INFUSION SITE SWELLING	0/87 (0%)	0	6/83 (7.2%)	13
LOCAL SWELLING	0/87 (0%)	0	5/83 (6%)	6
PAIN	4/87 (4.6%)	4	7/83 (8.4%)	13
PYREXIA	8/87 (9.2%)	11	13/83 (15.7%)	26
Infections and infestations
BRONCHITIS	6/87 (6.9%)	6	8/83 (9.6%)	12
CELLULITIS	0/87 (0%)	0	5/83 (6%)	5
CHRONIC SINUSITIS	1/87 (1.1%)	1	5/83 (6%)	6
GASTROENTERITIS	3/87 (3.4%)	3	5/83 (6%)	5
GASTROENTERITIS VIRAL	3/87 (3.4%)	3	9/83 (10.8%)	12
INFLUENZA	5/87 (5.7%)	5	5/83 (6%)	6
NASOPHARYNGITIS	4/87 (4.6%)	4	5/83 (6%)	10
POST PROCEDURAL INFECTION	1/87 (1.1%)	1	7/83 (8.4%)	7
SINUSITIS	14/87 (16.1%)	19	35/83 (42.2%)	59
UPPER RESPIRATORY TRACT INFECTION	8/87 (9.2%)	9	32/83 (38.6%)	49
URINARY TRACT INFECTION	6/87 (6.9%)	6	7/83 (8.4%)	7
VIRAL INFECTION	3/87 (3.4%)	6	9/83 (10.8%)	10
VIRAL UPPER RESPIRATORY TRACT INFECTION	2/87 (2.3%)	2	7/83 (8.4%)	11
Injury, poisoning and procedural complications
CONTUSION	2/87 (2.3%)	2	6/83 (7.2%)	8
PROCEDURAL PAIN	0/87 (0%)	0	5/83 (6%)	5
Musculoskeletal and connective tissue disorders
ARTHRALGIA	1/87 (1.1%)	1	13/83 (15.7%)	16
BACK PAIN	2/87 (2.3%)	2	7/83 (8.4%)	8
MYALGIA	3/87 (3.4%)	5	11/83 (13.3%)	21
PAIN IN EXTREMITY	4/87 (4.6%)	6	5/83 (6%)	9
Nervous system disorders
DIZZINESS	3/87 (3.4%)	3	11/83 (13.3%)	14
HEADACHE	24/87 (27.6%)	53	27/83 (32.5%)	63
MIGRAINE	3/87 (3.4%)	4	6/83 (7.2%)	14
Respiratory, thoracic and mediastinal disorders
ASTHMA	7/87 (8%)	8	14/83 (16.9%)	28
COUGH	3/87 (3.4%)	4	7/83 (8.4%)	8
NASAL CONGESTION	4/87 (4.6%)	4	8/83 (9.6%)	10
OROPHARYNGEAL PAIN	2/87 (2.3%)	3	5/83 (6%)	7
RHINITIS ALLERGIC	4/87 (4.6%)	5	5/83 (6%)	6
Skin and subcutaneous tissue disorders
ERYTHEMA	1/87 (1.1%)	1	6/83 (7.2%)	6
RASH	2/87 (2.3%)	2	6/83 (7.2%)	6
URTICARIA	1/87 (1.1%)	1	6/83 (7.2%)	6
Vascular disorders
HYPERTENSION	0/87 (0%)	0	6/83 (7.2%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Baxter's agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 12 months after study completion. Baxter requires a review of results communications (e.g., for confidential information) ≥30 days prior to submission or communication. Baxter may request an additional delay of ≤60 days eg, for intellectual property protection